Total 17 Director/C-Level Manufacturing job vacancies in Manufacturing / Production category in Malaysia

The Role:

This position is part of Moderna’s Manufacturing Sciences and Technology (MST) team responsible for ensuring robust production of Drug Substance (DS) using our mRNA manufacturing platform at our Norwood site.  The Director/Senior Director will have full responsibility for both clinical and commercial GMP manufacturing support and be an integral member of the internal manufacturing leadership team.

Here’s What You’ll Do:

• Lead MS&T teams supporting cGMP drug substance manufacturing of Moderna’s late-stage clinical and commercial mRNA products, as well as select critical starting raw materials and starting materials

• Lead MS&T teams providing technical support for process monitoring, on-floor support, change control, deviation investigations, and CA/PA for all DS workcenters – DNA, chemistry, small-scale clinical DS production, and large-scale clinical/commercial DS production

• Lead MS&T teams providing centralized investigation and CA/PA leadership support on behalf of the internal manufacturing organization

• Lead technical product stewards responsible for managing the site-based new product introduction and process qualification strategies across all technologies and scales, across the program lifecycle

• Author, review, or otherwise contribute to clinical and commercial regulatory filings and health authority question responses.  Support inspection readiness and response activities.

• Develop MS&T strategy, plan resource needs and hire and manage employees to meet organizational needs for the present and future. 

• Communicate with executive leadership to drive alignment of critical decisions, strategy, and risk mitigations.  

• Collaborate extensively with Manufacturing, Quality, Digital, Technical Development, Supply Chain and others to ensure operational excellence in making product.

• Obsessively focus on decreasing variability in the manufacturing environment through practical application of data and operational.

• Collaborate with multiple functions to ensure the manufacturing site maintains a high state of compliance through continued improvements in raw material control, control of microbial contamination, control of consumables quality, control of cleaning, and control of equipment performance. Monitor and improve these critical manufacturing areas through continuous monitoring, data analytics, and collaboration with QA, QC, and Facilities & Engineering.

Here’s What You’ll Bring to the Table: 

• Biochemical engineer, chemical engineer, or biological/chemistry science degree with >12+ years of experience in the pharmaceutical or biotechnology industry.  Advanced degree preferred (MS, Ph.D.) 

• Prior leadership experience managing MS&T, Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company.  Demonstrated ability to mentor and develop a technical staff. 

• Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI). 

• Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development. 

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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Unique opportunity for those experienced in the manufacturing field looking to grow their career in Defence Your new company
An exceptional opportunity awaits for an Industry Director within a reputable defence company. This organisation has a strong track record of leadership and innovation in the defence field. As part of the senior management team, the successful candidate will shape strategy, manage human, financial, and physical resources, and ensure the effective implementation of policies and long-term plans. Responsibilities include overseeing product manufacturing, maintaining production, performance, and quality standards, and driving increased productivity and efficiency across the team and supply chain. Safety, quality, financial, and delivery goals will be rigorously met. Location: North Regional Victoria
Reporting directly to senior management, you'll join a supportive team where mentorship and guidance will facilitate your growth in this role. We encourage candidates from diverse backgrounds, including those outside the defence sector, to apply.


Implement the industrial strategy and in particular the human organisation, financial and material means which guarantee the proper execution of the policies and plans adopted, for the short, medium and long term.
Manage industrial activities, direct and develop the team
Ensure that the engineering, Process Engineering, Supply Chain and Operations teams provide support to the production/repair teams
Ensure the industrial sector is competitively structured (transformation plan)
Sponsor and promote the LEAN transformation approach (CLPF, Andon & KAIZEN, etc.)
Interfacing the implementation of future growth into operations by translating demand towards meeting future needs through overseeing operational changes
Heavily involved with site manufacturing, site management and supply chain management

What you'll need to succeed

Degree Qualified Engineer/Scientist or other relevant qualification
Senior leadership experience within a complex multisite engineering environment leading team of executives in a production environment.
Extensive experience in developing technical strategic plans to support a complex and varied design engineering environment.
Experience driving organisational transformation to optimise business performance within a complex environment
Problem solver, a natural leader, and creative so far as being able to bring proactive and innovative solutions to problem areas of the business
Commercial and business experience in senior management

What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV to ali.kavanagh@hays.com.au . If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career. Please click here to apply.

Job Description

The primary focus of the Associate Director/Principal Engineer, External Manufacturing role is to oversee Vertex’s critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact.  The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.  The candidate will be located either at the cell and gene therapy CDMO’s site and/or be able to travel to those sites routinely as a “Person-in-Plant”. The successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. 

Candidates can be located in/near 1. Maastricht, Netherlands 2. Netherlands 3. London  

Key Responsibilities:

• Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
• Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears' at the CDMO for flawless execution of commercial operations
• Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities.  It is anticipated that routine Person-in-Plant oversight will decrease over time.
• Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices).
• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply.  This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
• Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
• Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization.
• Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements.
• Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
• Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments.
• Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
• Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
• Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership.
• Lead continuous improvement initiatives to affect timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Live the Vertex values.

Minimum Requirements:

• BSc in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with extensive relevant experience in biotech or pharma industries, working with or in GMP facilities within biotechnology industry.
• Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps
• Ability to travel, national and international, up to 30%
• Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. 
• Solid experience in equipment and facility qualification and validation for ATMP CDMO’s 
• Represent Vertex as a leader when issues arise.

#LI-Hybrid

#LI-SM1

Company Information

Job Description

Mexico City

Education Level:

Bachelor’s Degree in Engineering (Electrical, Mechanical, Computer, Technology), Information Technology, or Data Science

Years of experience:
12+ years of industry specific experience

Summary:

The Director of Manufacturing Execution Systems (MES) will be responsible for the entire CBI Beer Division’s Portfolio of Manufacturing Execution System Applications. This position will be responsible for the entire life cycle of the suite of our application in our industrial environment including integration and optimization of our Brewing, Utilities, Packaging, and Logistics MES applications. This includes but is not limited to Packaging MES (PLAS - Wonderware), Brewing MES (Aveva), OEE Reporting - TrakSYS (Parsec), LGV SMART and Traffic Manager (Elettric 80), WMS - Systore (System Logistics), Battery Management Applications (Kaitek), Glass Inspection Applications (IQ Scan), Laboratory Information Management Systems (LIMS), Building Management Systems (BMS) and Advanced Planning Systems (APS). He/She will be responsible for the development of the application architecture and software design specifications to support the build outs taking place in all breweries (currently Nava, Obregon, and Veracruz). The director must have a strategic focus and anticipate potential business changes to ensure logistics capacities and throughputs exceed the capacity of the brew house and packaging lines. The Director must build strong relationships with local and corporate leadership and continuously engage the business to ensure that all MES applications are delivering against current needs and preparing for future enhancements which drive business value. The Director will manage a team of project and application experts ensuring that each functional area delivers best in class application solutions that integrate well into the larger network of MES applications. The Key areas of focus for this Director will be Warehouse Management System (WMS) applications which support both traditional warehousing, as well as High Density Storage and Retrieval Systems, Laser Guided Vehicle Management Systems, Manufacturing Execution Systems (MES), and OEE and KPI tracking software suites. The director must have a strong history of operational technology & automation experience and leverage those skills to achieve seamless integrations with the brewery’s end to end supply chain system

Responsibilities:

1. Strategic Planning & Specification Management (50%). Responsible for the program management and prioritization of all Beer Division MES Projects and Initiatives, from R&D to implementation.

2. Responsible for entire life cycle

3. Define application architecture and integration strategy amongst all MES applications. Define interface requirements to drive standardization across applications and breweries alike.

4. Manage key vendor relations and ensure we are staying abreast of new technology.

5. Develop obsolescence mitigation plans for all MES applications to ensure our critical systems are supported at the Operating System, Database, and Application levels.

6. Manage and guide team members in developing and delivering solutions that fit within CBI’s standards and align with our application architecture.

7. Manage all feasibility studies related to new product development, material consolidation, building expansions, etc.

8. Implement corporate Beer Division Automation Standards and Specifications.

9. Create KPI and performance metrics to measure success of individual applications and the system.

10. Implementation & Operations (50%). Review MES, WMS, & LGV system performance and KPIs to ensure capacity greater than packaging peak rates. This includes supplying raw materials to the line, taking finished goods to the warehouse, and shipping pallets to the docks.

11. Drive optimization of all material flows within the production, receiving, and shipping areas. This includes but is not limited to cans, bottles, lids, crowns, case material, partitions, pallets, etc.

12. Identify opportunities for increased throughput, reduced maintenance resources, and higher systems reliability.

Skills:

• Demonstrates leadership and has experience in managing people.

• Able to identify and analyze problems quickly, recommending and implementing flexible and creative solutions based on customer and business needs

• Demonstrated ability to effectively organize and manage multiple tasks as projects, ensuring completion to meet deadlines.

• Excellent attention to detail on multiple simultaneous tasks.

• Excellent verbal presentation skills. Excellent written communications skills and ability to document system procedures in an understandable format.

• Strong interpersonal skills.

• Bilingual is a plus

Location

Mexico City

Additional Locations

Job Type

Full time

Job Area

Operations and Production

Equal Opportunity

Constellation Brands is committed to a continuing program of equal employment opportunity. All persons have equal employment opportunities with Constellation Brands, regardless of their sex, race, color, age, religion, creed, sexual orientation, national origin or citizenship, ancestry, physical or mental disability, medical condition (cancer or genetic characteristics), marital status, gender (including gender identity or gender expression), familial status, military or veteran status, genetic information, pregnancy, childbirth, breastfeeding, or related conditions (or any other group or category within the framework of the applicable discrimination laws and regulations).

KONE, founded in 1910, is one of the largest, award-winning elevator companies in the world and our offering for employees is as competitive as our offering for customers. Not only do we provide highly competitive salaries, company vehicles for specific roles, and world-class benefits for our salaried employees - we also pride ourselves on our culture and principles. Innovation, sustainability, collaboration and ethical business practices are just some of the pillars that we use to define our own success.

The Manufacturing Director plans, directs and coordinates all manufacturing operations for production, machinery, processing and packaging departments. He/she develops priorities based on production introduction, equipment efficiency, and materials. He/she creates schedules and staffing requirements based on determined priorities. He/she establishes manufacturing and quality control standards and develops budget controls and plans that will improve the efficiency and productivity of the organization’s manufacturing operations.

The Purpose and Scope of the role is to:

• Manage KSU Escalator Supply Unit - US (ESM), ensure proper execution of global strategy and achievement of respective KONE deliverables.

• Develop a culture of performance improvement while fostering the utilization of LEAN / Six Sigma principles and techniques. 

• Champion the implementation of Supply Excellence in operations.

• Actively support Category Management initiatives locally and globally.

• Champion unit personnel professional development by coaching, mentoring, providing feed-back and executing performance appraisals.

• Actively support SOA strategic and tactic initiatives.

• Adhere to all legal, union and personal requirements according to the rules and regulations.

ESSENTIAL JOB DUTIES

• ​Manage and control ESM supply operation and develop new manufacturing concepts.

• Ensure cost competitiveness, quality and code complying deliveries to the customer.

• Facilitation of all production processes from orders received, purchasing etc. to shipment of products.

• Ensure complete products, which are shipped on time.

• Harmonize global processes and documentation.

• Ensure correct staffing levels in all areas.

• Ensure personnel performance adheres to KONE expectations, rules and policies.

HIRING REQUIREMENTS

The desired candidate will have:

• Bachelor's or Master's degree in Manufacturing, Supply Chain or relevant field.

• 5 to 7 years of prior production management and leadership experience within an industrial company.

• Knowledge of Lean 6 sigma, highly preferred including demonstrated success with production efficiency improvements, quality improvements (Need to show examples); scheduling, processing, planning and efficiency, capital mgmt. budgets, understanding of maintenance and facilities.

• Strong people leader with people development; driver, good cross functional background - would like experience in more than manufacturing; has holistic approach so they can focus on full chain.

What can KONE offer you?

• A chance to work with products that are used by millions of people every day; products and services that are widely recognized for their quality and innovation; and the opportunity to develop our existing product family and customer offering.

• An excellent opportunity to work with leading technologies and partners on a truly global scale and within a global portfolio.

• International career opportunities

• A genuinely multicultural work environment - we have colleagues from 25 countries

• Flexible working hours and remote working opportunities

• Career Development

• Competitive medical benefits

• Matching 401K and Pension Plan

• 20 days PTO plus 10 holidays

• KONE’s elevate your health program

*Applicant must be currently authorized to work in the United States on a full-time basis.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

#IND

At KONE, we are focused on creating an innovative and collaborative working culture where we value the contribution of each individual. Employee engagement is a key focus area for us and we encourage participation and the sharing of information and ideas. Sustainability is an integral part of our culture and the daily practice. We follow ethical business practices and we seek to develop a culture of working together where co-workers trust and respect each other and good performance is recognized. In being a great place to work, we are proud to offer a range of experiences and opportunities that will help you to achieve your career and personal goals and enable you to live a healthy and balanced life.

Read more on www.kone.com/careers

Job Description

PLEASE NOTE: The primary location for this role is Edinburgh. A second possible location would be London.

The primary focus of the Associate Director/Principal Engineer, External Manufacturing role is to oversee Vertex’s critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact.  The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.  The candidate will be located either at the cell and gene therapy CDMO’s site and/or be able to travel to those sites routinely as a “Person-in-Plant”. The successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities. 

Key Responsibilities:

• Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
• Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears' at the CDMO for flawless execution of commercial operations
• Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities.  It is anticipated that routine Person-in-Plant oversight will decrease over time.
• Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices).
• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply.  This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
• Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
• Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization.
• Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements.
• Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
• Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments.
• Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
• Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
• Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership.
• Lead continuous improvement initiatives to affect timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Live the Vertex values.

Minimum Requirements:

• BSc in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 8 years of relevant experience in biotech or pharma industries, working with or in GMP facilities within biotechnology industry.
• Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps
• Ability to travel, national and international, up to 30%
• Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience. 
• Solid experience in equipment and facility qualification and validation for ATMP CDMO’s 
• Represent Vertex as a leader when issues arise.

#LI-HYBRID #LI-SM1

Company Information

Job Description

An Associate Director of Vaccine Manufacturing provides support and expertise to the Integrated Process Team in support of vaccine manufacturing and distribution. The individual collaborates with appropriate internal and external partners to ensure the Integrated Process Team actions meet or exceed regulatory and company standards. There is collaboration with site leadership to determine optimum systems and processes leading to stable and effective results. The Associate Director directs teams to ensure business goals and budgets expectations are met and leads by example and displays strong coaching, Company Production Systems (CPS) principles, inclusive behaviors and best practices.
 

The position will manage the activities within the Integrated Process Team and collaborate with Regulatory Affairs, Quality, Environmental Health and Safety, Engineering and Human Resources.

Responsibilities

Essential Functions

• Direct the Integrated Process Team with comprehensive management of all activities required to successfully support vaccine manufacturing
• Ensure compliance to corporate, site and departmental procedures associated with the manufacturing of product, and ensuring team is trained on new or revised processes or procedures
• Review and approve Quality Notifications
• Author, review and approve SOPs
• Serve as subject matter expert for product release matters
• Lead and/or participate in project management initiatives as appropriate to Integrated Process Team
• Direct support of regulatory inspections and audits
• Direct support of validation activities and all other associated Quality related activities pertaining to the Integrated Process Team
• Identify and resolve technical and operational issues; collaborate with others to resolve issues
• Implement Integrated Process Team plans and priorities based on division scorecard and yearly Hoshin Kanri
• Manage and forecast budget of Integrated Process Team

Competencies

• Technical expertise in vaccine production (antigen, formulation, fill, bioreactor/ SUB (single use bioreactors) bacterial fermentation, monoclonal antibodies, emulsification)
• Manages individual contributors (professional employees) and managers
• Proven people development and coaching skills
• Working knowledge of aseptic techniques and aseptic operations
• Contributes to the performance results of a department
• Adapts departmental plans and priorities to address resource and operational opportunities
• Decisions are guided by policies, procedures and business plan
• Provides technical guidance to employees, colleagues or clients
• Anticipates and interprets client and/or customer needs to identify solutions
• Proven ability to use scientific problem solving and lean manufacturing principles to solve complex issues
• Working knowledge of regulatory requirements in accordance with cGMP and/or USDA manufacturing operations
• Proven project management skills
• Excellent communication skills; able to communicate company and site strategies to direct reports and IPT employees
• Proficiency in computer systems and applications
• Must be able to lead in a team-based empowered culture
• Ability to work freely and effectively with peers; display strong interpersonal and organizational skills
• Knowledge and the ability to coach Lean methodology

Education Requirements

•  Bachelor's degree in Life Science, Engineering or related field of study.

Experience and Skills

•  Five (5) or more years relevant experience in the vaccine manufacturing/ operations industry
• Three (3) or more years of supervisory/ management (people, budget, organization and results) experience or equivalent.
• Strategic and effective Team building skills that focus on mentoring and coaching
• Positive and effective communication skills
• Demonstration of high analytical and logical problem-solving abilities
• Working knowledge of aseptic techniques
• Strong knowledge of manufacturing principles and operating systems

Preferred

•  SAP and inventory control
• LSS Green Belt or higher (LL2/LL3)
• Knowledge of 8-Step Problem Solving, Kata and other lean coaching tools

#EBRG

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Key Responsibilities:

• Lead and manage our ASMPT's semiconductor machine manufacturing and mold chase manufacturing operations, ensuring adherence to production schedules and quality standards.
• Develop and implement strategies to optimize manufacturing processes, minimize downtime, and maximize throughput.
• Collaborate with cross-functional teams to drive continuous improvement initiatives and innovation in mold chase methodologies.
• Oversee the recruitment, training, and development of manufacturing staff, fostering a culture of excellence and teamwork.
• Analyze production data and metrics to identify areas for improvement and implement corrective actions as needed.
• Ensure compliance with regulatory standards, safety protocols, and quality control measures.

Qualifications:

• Min. Bachelor's degree in Engineering, Manufacturing, or related field; advanced degree preferred.
• Proven track record of at least 8 years in a leadership role within manufacturing, specifically in mold chase operations.
• Strong understanding of mold chase processes, equipment, and technologies.
• Demonstrated experience in implementing lean manufacturing principles and driving continuous improvement initiatives.
• Exceptional leadership, communication, and problem-solving skills.
• Ability to thrive in a fast-paced environment and drive results through collaboration and innovation.

Join our team and be part of a company dedicated to fostering a culture of innovation and excellence. We offer a competitive compensation package, opportunities for professional growth, and a collaborative work environment that values diversity and inclusivity.

Job Description

The primary focus of the Associate Director/Principal Engineer, External Manufacturing role is to oversee Vertex’s critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact.  The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.  The candidate will be located either at the cell and gene therapy CDMO’s site and/or be able to travel to those sites routinely as a “Person-in-Plant”. The successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

Candidates should be located in /near Boston, MA or Portsmouth, NH.

Key Duties and Responsibilities:

• Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
• Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears' at the CDMO for flawless execution of commercial operations
• Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities.  It is anticipated that routine Person-in-Plant oversight will decrease over time.
• Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices).
• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply.  This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
• Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
• Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization.
• Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements.
• Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
• Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments.
• Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
• Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
• Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership.
• Lead continuous improvement initiatives to affect timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Live the Vertex values.

Education and Experience:

• BS /BA in in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 8+ years of relevant experience in biotech or pharmaceutical industries, working with or in cGMP facilities within the biotechnology industry.
• Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps
• Ability to travel, national and international, up to 30%
• Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.
• Solid experience in equipment and facility qualification and validation for ATMP CDMO’s
• Represent Vertex as a leader when issues arise.

#LI-SV1

#LI-Remote

Salary range: $152,000 - $228,000 annually

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. 

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. 

Company Information

Job Description

The primary focus of the Associate Director/Principal Engineer, External Manufacturing role is to oversee Vertex’s critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact.  The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities.  The candidate will be located either at the cell and gene therapy CDMO’s site and/or be able to travel to those sites routinely as a “Person-in-Plant”. The successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

Candidates should be near Boston, MA or Portsmouth, NH and be willing to travel to CDMO's in these locations as well as Belgium and Netherlands.

Key Duties and Responsibilities:

• Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
• Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears' at the CDMO for flawless execution of commercial operations
• Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities.  It is anticipated that routine Person-in-Plant oversight will decrease over time.
• Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices).
• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply.  This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness.
• Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
• Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization.
• Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements.
• Act as the key liaison to facilitate periodic CAPA effectiveness reviews at CDMOs.
• Establish a robust tracking and reporting process to ensure compliance with KPI’s, internal/external audit observation deadlines or other regulatory commitments.
• Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments.
• Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
• Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership.
• Lead continuous improvement initiatives to affect timely resolution of supply issues.
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders.
• Live the Vertex values.

Education and Experience:

• BS /BA in in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 8+ years of relevant experience in biotech or pharmaceutical industries, working with or in cGMP facilities within the biotechnology industry.
• Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps
• Ability to travel, national and international, up to 30%
• Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.
• Solid experience in equipment and facility qualification and validation for ATMP CDMO’s
• Represent Vertex as a leader when issues arise.

#LI-SV1

#LI-Remote

Salary range: $152,000 - $228,000 annually

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. 

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. 

Company Information

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will be part of the Site Leadership team and lead the site by setting and delivering ambitious targets on supply, quality, safety and cost in order to achieve the vision of being a fast flexible and focused site. You will collaborate with the Site Leadership team and all functions to drive the delivery of world class manufacturing. Your expertise in the manufacturing domain will help Pfizer determine the manufacturing methods, procedures and tooling requirements. 

As a Director, you are a subject matter expert and leverage your knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the manufacturing division. Your ability to interpret your division's strategy will establish business priorities that support and set long-term direction for the division. Your managerial skills will help us manage and lead people, technological and financial resources within the division.

It is your dedication that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

• Set objectives for and manage multiple projects and ongoing work activities within a division or subdivision.

• Develop and implement strategic direction for product or process improvements.

• Manage financial controls and practices as appropriate for site management.

• Ensure operations are in compliance with corporate standards as well as federal and local regulations.

• Participate in facility planning to ensure that both short-term and long-term product/process business objectives are met.

• Ensure the operational performance objectives and supporting functions are well-defined, executed and delivered on time, and the SOD Strategic Priorities are aligned and support the overall Pfizer Global Supply vision.

• Ensure that {Current} Good Manufacturing Practices {part of GxP} and safety training for all site staff within department is conducted in a timely and efficient manner in order to meet regulatory compliance requirements.

• Work with Supply Chain, Regulatory Affairs, Technical Services, Environment, Health & Safety and others to evaluate production needs, resolve issues, provide resources and reset direction in order to maximize effective.

• Oversee investigations and Operational Excellence initiatives, ensuring the use of tools to improve quality, cost, safety and cycle time.

• Engage with HR to ensure effective talent management culture and identify development opportunities for colleagues and prepare them for future promotional growth.

Qualifications

Must-Have

• Bachelor's Degree

• 10+ years ‘experience

• Demonstrated ability to plan, implement, and achieve significant, complex goals and objectives

• Demonstrated experience in pharmaceutical/medical device/consumer environment with a track record of increased responsibilities including experience in operations

• Training in compliance (cGMP) in Pharmaceutical industry, quality, relevant Standard Operating Procedure's/Policies, Operational Excellence tools and processes used at site

• Excellent planning and project management skills, including ability to handle multiple projects, simultaneously and manage against a work plan

• Customer focused, cost effective decision in a competitive environment

• Strong people management experience

• Excellent verbal, written and interpersonal communication skills, including presentation skills

• Fluent in German

Nice-to-Have

• Master's degree

  

Together we stand for: 

#LI-PFI

Manufacturing

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. 

Owens & Minor teammate benefits include:

• Medical, dental, and vision insurance, available on first working day
• 401(k), eligibility after 30 days of employment
• Employee stock purchase plan
• Tuition reimbursement
• Development opportunities to grow your career with a global company

Summary

Product and Healthcare Service (P&HS) IT team delivers enterprise level technology stack, products, and platforms supporting key enterprise functions including Supply Chain, ERP, 3PL and Distribution.

The  IT Director,  Manufacturing and Distribution will be part of our P&HS function and report directly to the Head of P&HS IT. IT Director,  Manufacturing and Distribution, you will be responsible for leading and handling all aspects of the 3PL, Distribution, Warehouse Management and Manufacturing technology functions within our organization. You will play a critical role in driving digital transformation and leveraging technology to optimize our operations.

The ideal candidate will have a good background in Supply Chain, 3PL, Warehouse Mgmt. and Distribution, extensive knowledge of technology solutions, a proven track record of successfully implementing and leading large-scale Distribution and Warehouse Mgmt. initiatives, and will be accountable for managing budget effectively.

This role will work extensively with the supply chain, operations and product teams and will need to collaboratively partner across functions to drive effective outcomes. Experience in leading teams and directing both internal and third party resources will be necessary for success. Candidates should be comfortable leveraging analytics to drive insights and using storytelling to update executives and drive alignment across teams.

This is an exciting opportunity for an experienced technology leader to help shape the transformation of infrastructure and operations products and services to the entire Owens and Minor environment.

Responsibilities:

• Develop and implement the overall  strategy for Warehouse Mgmt, 3PL, Distribution technologies, aligned with the organization's objectives and growth plans.
• Lead a team of technology professionals, providing guidance, mentorship, and support to drive dedication and achieve departmental goals.
• Collaborate with cross-functional teams including operations, logistics, procurement, and IT to identify technology needs, prioritize initiatives, and ensure seamless integration with existing systems.
• Assess current technology landscape, identify gaps, and recommend innovative solutions to enhance efficiency, visibility, and responsiveness.
• Lead the selection, implementation, and integration of supply chain technology systems, such as warehouse management systems (WMS), transportation management systems (TMS), demand planning, and inventory optimization tools.
• Oversee vendor relationships and contracts, ensuring effective partnerships and optimal utilization of external resources.
• Stay abreast of industry trends, emerging technologies, and best practices in relevant technology, and apply relevant knowledge to drive continuous improvement.
• Establish and monitor key performance indicators to measure the effectiveness and efficiency of  technology initiatives, providing regular reports and insights to senior leadership.
• Develop and run the  technology budget, ensuring resource allocation aligns with strategic objectives and delivers a positive return on investment.
• Proactively identify potential risks, challenges, and dependencies across programs, and develop mitigation strategies to ensure successful program outcomes
• Foster a culture of innovation, collaboration, and continuous learning within the team.

Qualifications

Basic Qualifications

• Demonstrable experience in Supply Chain Management, with a focus on technology and digital transformation
• Strong leadership skills with a demonstrated ability to lead and motivate multi-functional technology teams
• Extensive knowledge of supply chain technology solutions including WMS, and TMS
• Experience managing large-scale technology implementations and integrations within complex supply chain environments
• Strong analytical and problem-solving skills, with the ability to use data and metrics to drive decision-making

Preferred Qualifications

• Experience with SAP EWM or Blue Yonder WMS
• Experience working in a global or multi-national organization a plus
• Experience working in Warehouse and Distribution Companies

Experience

• 10+ years of experience in supply chain management with a focus on technology and digital transformations

If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.

Associate Director, External Manufacturing Operations

The External Manufacturing Operations Associate Director, is accountable for meeting customer demand at the Contract Manufactures (CMO's) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of the responsible cross functional teams and their work in partnership with those CMO’s while leveraging lean manufacturing principles and the end to end (E2E) supply chain.

The External Manufacturing Operations Associate Director supports the Focus Factory Lead and serves as a point of contact for dealings between our Manufacturing Division and the CMO and establishes a strong business partnership as well as boundaries and ground rules of engagement. External Manufacturing Operations Associate Director will assist in our relationship with the contract manufacturer to deliver commercial supply or project execution through technology transfers.

The individual will participate on a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).

Main responsibilities include but are not limited to:

• Ensures compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management (SAP entries, Logistics); Technology issues; Oversight of shop floor production (determining when functional subject matter expertise should be deployed to the External Party’s (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management in the Supply Chain to ensure and optimize flow of materials.
• Is frequently present at their external partners site on the production floor, builds a strong interdependent relationship with the sites leadership team and is able to (“read a site”) assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans.
• Partners with internal External Manufacturing team members including; Procurement, Quality, and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc.
• Participates in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/Procurement/Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Sour of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
• Ensures there is a plan with clear actions and timelines in place to delivery this SOS or NPI.
• Works with the external partner to understand CMO capacity (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.) and future capacity based on agreed improvements.
• Is accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
• Is accountable for inventory control. Depending on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
• Acts as our Company continuous improvement system leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
• Supports the external partner periodic Business and Operations Review Meetings. Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets.
• Prepares an annual “state of the union” presentation for the relationships she or he manages which includes successes and failures in order to leverage across External Manufacturing Organization.
• Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc.

Qualifications:

• Bachelor’s degree preferably in the Engineering, Science or Business and a minimum 8 years’ experience in commercial /business and manufacturing (biologics operations, quality, technology, planning), roles required with a significant portion in management/leadership positions.
• At least two (2) years of experience in management/leadership positions.
• Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and compliance risk in Biologics Operations.
• Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
• Has skills to understand and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
• Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
• Must possess excellent interpersonal, communication, collaboration and negotiation skills to work outside boundaries as a norm.
• Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
• Ability to apply understanding of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
• Direct Health Authority Audit experience is desirable.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Job Description

Key Responsibilities

1. Provides executive leadership to a major manufacturing / supply chain function supporting a large and complex business unit. May lead functional operations at multiple manufacturing sites. Establishes and monitors production using metrics/budgets through systems, and initiates appropriate corrective action as needed and based on results. Establishes and controls project schedules, timelines.
2. Plans and evaluates optimal resource utilization and efficiency of operation to minimize costs and allow for on-time delivery of product to customers. Accurately establishes plant capacity.
3. Directs, guides, monitors, and evaluates Operations Team personnel to accomplish specific production and supply chain goals consistent with established operational, housekeeping (5S), and safety procedures and processes. Engage in problem solving in complex situations and process improvements in streamlining work processes.
4. Leads continuous improvement efforts and projects to refine production methods and processes to produce quality products that meet customer requirements in the most cost-effective manner.
5. Identifies and pursues new technologies to improve production, increase efficiency and resource utilization and maximize profitability.
6. Works closely with members of Senior and Executive Management to align overall operations development with business needs/opportunities. Promotes an environment of cooperation and trust.
7. May provide ownership / leadership for a major divisional function, project, or program (i.e., Inventory Management, AMPS/Lean, Responsiveness / Agility). Provides leadership, guidance, mentorship, and personal development of his/her direct reports in the areas of daily operational management, systems development, and optimization.
8. Identifies process and quality changes designed to improve manufacturing or department capabilities. Drives Lean, Safety and Quality. Takes corrective action.

Functional Knowledge

• Demonstrates broad and comprehensive understanding of different systems, theories and practices

Business Expertise

• Applies broad industry and commercial awareness to drive financial and operational performance across business unit, department or sub-functions

Leadership

• Leads through subordinate managers of managers; executes segment/functional business plans and contributes to the development of segment/functional strategy

Problem Solving

• Directs the resolution of highly complex or unusual business problems applying advanced analytical thought and judgment

Impact

• Guided by segment/functional strategy, impacts results of a department, business unit or sub-function or facilitates the work done by other segments/functions by providing support to impact the business

Interpersonal Skills

• Negotiates and influences the opinions of others at the senior executive level and in external organizations; exercises sensitivity to the audience

Position requires understanding of Applied Materials global Standards of Business Conduct and compliance with these standards at all times. This includes demonstrating the highest level of ethical conduct reflecting Applied Materials' core values.

Are you a dynamic operations leader from manufacturing sectors with a passion for delivering operational excellence? Do you have a proven track record of results in fast-paced, consumer-facing sectors? If so, we have an exciting opportunity for you to join our team as an Operations Manager/ Director.

Your new company
A growing and innovative company that produces high-quality products in the consumer goods sector. Due to continued growth and increased demands, they are seeking to appoint an experienced Operations Manager/ Director to oversee and manage all aspects of operations and ensure they continue to meet & exceed targets, standards, and expectations, while maintaining a safe, efficient and sustainable operation.

About your new role:
Forming part of the senior leadership team, you will head up operations; leading and influencing excellence, accountable for multi-functional teams, production, warehouse, logistics, HSE and maintenance, amongst others. You will create and maintain a culture of collaboration and form a collective approach towards manufacturing excellence and high-quality outputs.

Other typical duties will include:

• Lead, motivate, and develop a team of managers and staff across various departments and functions
• Plan, implement, and monitor production schedules, budgets, and resources to ensure optimal performance and output
• Ensure compliance with all relevant health and safety, environmental, and quality regulations and standards
• Drive continuous improvement and innovation initiatives to enhance productivity, efficiency, quality, and customer satisfaction
• Liaise and communicate effectively with internal and external stakeholders, including suppliers, customers, and senior management
• Identify and resolve any operational issues or challenges that may arise
• Keep up to date with the latest trends, developments, and best practices in the textile and manufacturing industry

To be successful in this role, you will have:

• A degree or equivalent qualification in operational, engineering, manufacturing, business, or a related field
• At least 5 years of experience in a senior management role in a consumer manufacturing environment
• A strong knowledge and understanding of production processes, technologies, and quality standards
• A proven ability to lead, manage, and inspire teams and individuals
• A strategic and analytical mindset, with excellent problem-solving and decision-making skills
• A customer-focused and results-oriented approach, with a commitment to excellence and innovation
• Excellent communication, interpersonal, and negotiation skills
• A flexible and adaptable attitude, with a willingness to learn and grow
• The right to work in the UK
• UK driving license

What you need to do now
If you\'re interested in this role, click \'apply now\' to forward an up-to-date copy of your CV, or call us now.
If this job isn\'t quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

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