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Job Description
The Director of PAT has central responsibility for global, virtual manufacturing
operations in a technical area, overseeing activities of staff and adapting personnel deployment to changing priorities. The Director champions continuous improvement of activities and relationships within and outside Vertex. The Director takes a leadership role in company-wide initiatives and guides resolution of critical issues impacting manufacturing operations.
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select
On-Site: work five days per week on-site with ad hoc flexibility.
KEY RESPONSIBILITIES:
TECHNICAL AND COMMUNICATION SKILLS:
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex 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, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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 recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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Job Description
A new opportunity has arisen for a Drug Substance Process Operations, Associate Director (DPSO AD) to join the team at our newly constructed state Biologics Innovation facility located at our company site in Dunboyne, County Meath, Ireland.
The Biologics Innovation Xceleration facility, is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. The site provides Biologics Drug Substance and Cell Banking manufacturing for Clinical Supply, Registration & Commercial Launch.
The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. A multi-product strategy for Technology Transfer and Facility Fit will enable the facility to adapt in a flexible and agile way for rapid product launch. The DPSO AD will be a member of the site Manufacturing Leadership team, reporting to the Head of Manufacturing. The successful candidate will be a key stakeholder in the deployment of the multiproduct strategy and will coordinate the introduction of new processes, materials, and technologies to the facility, as well as transfer of processes out. The successful candidate will be critical to the success of the facility to meet an accelerated Clinical Commercial-ready schedule.
The Associate Director of Drug Substance Process has a variety of key responsibilities.
• Leading a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical or Commercial campaigns.
• Overseeing the coordination efforts for Drug Substance Manufacturing Execution (DS Process Operations) intended to meet the requirements of New Product Introduction (NPI) schedule.
• Management of the Operations team, which includes hiring and building team capabilities to meet the operational requirements of the facility.
• Embedding a culture that aligns with the Ways of Working and is committed to both the facility and site priorities.
• Overseeing production planning and associated activities, integrated with the facility Multiproduct platform.
• Championing the implementation of the lights-out manufacturing philosophy. Establishing a working rhythm that allows for agility and movement of staff between Cell Expansion, Process Platforms for Fed Batch and Continuous Manufacturing, and Solution Supply. This includes designing a flexible skill matrix for training aligned with the working rhythm.
• Ensuring operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA).
• Accountable for the management of the Production Alarm System, Sample Management Processes (GLIMS), Change approver for MES, Delta V Recipes, and material BOMs, Manufacturing approver of process descriptions.
• Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with network partners for a common approach.
• Supporting the deployment of phase-appropriate Quality Management Systems (QMS) within the facility, including Change and Deviation Management.
• Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.
• Collaborating across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally.
The successful applicant will have the following education, skills, and experience:
• Degree level qualification in science or engineering.
• Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
• Proven experience in a leadership role with technical transfer experience in the biotech sector in any/all the following: Clinical Supply, Registration & Commercial Launch.
• Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing being a significant advantage.
• Delta V and MES (Manufacturing Execution System) knowledge and experience an advantage.
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
RegularRelocation:
InternationalVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Official account of Jobstore.
We’re building a relationship-oriented bank for the modern world. We need talented, passionate professionals who are dedicated to doing what’s right for our clients.
At CIBC, we embrace your strengths and your ambitions, so you are empowered at work. Our team members have what they need to make a meaningful impact and are truly valued for who they are and what they contribute.
To learn more about CIBC, please visit CIBC.com
What You’ll Be Doing
As Director, Process Optimization for Canadian Banking, you will join CIBC’s Chief Administrative Office (CAO) accountable to lead a team driving process change and modernizing procedures. You will engage relevant partners and users; lead and design processes and client journeys; assess client and stakeholder impact; and implement recommendations to radically simplify how we do business and serve our clients. You will also lead the review, update and distribution of internal procedures to front-line employees along with oversight dissemination and maintenance of supervisory reports to support an effective control environment.
As the catalyst for change, you will lead Business Risk Effectiveness initiatives on behalf of our Canadian Banking teams, acting as the defacto Regulatory Subject Matter Expert (SME), working collaboratively with our Legal and Compliance partners to challenge interpretation of regulations. You will assist with the lead of the coordination of the Process Optimization Executive Steering Committee (ESC) responsible for developing a portfolio and roadmap of optimization initiatives that support our strategy and delivering initiatives that measurably improve the effectiveness.
You will analyze and implement process changes with focus on simplification, consolidation and/or automation to ensure efficiency and effectiveness while ensuring processes remain aligned to our risk appetite and adhere to regulatory requirements. Your responsibility includes implementation an active continuous improvement culture across Wealth Management businesses in partnership with other CAO teams to source high impact opportunities to enhance productivity and reinforce a growth mindset. You will also scope and implement use cases to leverage artificial intelligence to improve reporting accuracy and turnaround.
You will lead a team of Consultants who will work with the Project Delivery team, Compliance, and Legal partners to ensure successful implementation of regulatory changes by focusing on adhering to regulatory requirements in the context of how we serve our clients today, and tomorrow. Your team will develop and implement remediation plans to close identified process gaps and risks, review and update internal procedures across Canadian Banking to ensure they remain current and in alignment to CIBC’s policies and risks. Your team will collaborate with partners to develop and maintain training approach to regulatory changes & frameworks.
You will define and manage strategic key performance indicators (KPIs) to ensure successful delivery of initiatives within appropriate spend budgets, track benefits and monitor sustainment of key regulatory change initiatives within defined thresholds, escalating where appropriate.
At CIBC we enable the work environment most optimal for you to thrive in your role. You’ll have the flexibility to manage your work activities within a hybrid work arrangement where you’ll spend 1-3 days per week on-site, while other days will be remote.
How You’ll Succeed
Who You Are
What CIBC Offers
At CIBC, your goals are a priority. We start with your strengths and ambitions as an employee and strive to create opportunities to tap into your potential. We aspire to give you a career, rather than just a paycheck.
We work to recognize you in meaningful, personalized ways including a competitive salary, incentive pay, banking benefits, a benefits program*, defined benefit pension plan*, an employee share purchase plan, a vacation offering, wellbeing support, and MomentMakers, our social, points-based recognition program.
Our spaces and technological toolkit will make it simple to bring together great minds to create innovative solutions that make a difference for our clients.
We cultivate a culture where you can express your ambition through initiatives like Purpose Day; a paid day off dedicated for you to use to invest in your growth and development.
*Subject to plan and program terms and conditions
What you need to know
CIBC is committed to creating an inclusive environment where all team members and clients feel like they belong. We seek applicants with a wide range of abilities and we provide an accessible candidate experience. If you need accommodation, please contact Mailbox.careers-carrieres@cibc.com
You need to be legally eligible to work at the location(s) specified above and, where applicable, must have a valid work or study permit.
Job Location
Toronto-81 Bay, 12th FloorEmployment Type
RegularWeekly Hours
37.5Skills
Business Controlling, Corporate Governance, Fraud Management, Leadership, People Management, Performance Management (PM), Risk Management, Team Development, Technical KnowledgeOfficial account of Jobstore.
* Note: This is a fixed term role for 12 months
The Role Responsibilities
· The Associate Director, Process Change role is primarily responsible for defining, documenting, and embedding complex global and/or local process and system change initiatives across Corporate Affairs, Brand & Marketing.
· The jobholder will collaborate and work closely with key stakeholders to effectively understand, document and embed critical process changes, ensuring clarity with stakeholders and impacted colleagues. The jobholder will take ownership and champion key process change initiatives and effectively engage stakeholders to ensure high adoption among colleagues. The process change initiatives will focus on broad planning, approval, creative content development and execution ways of working which impact a significant CABM population. In addition, the jobholder will collaborate with CABM’s Risk Management team to support key changes to the Process Universe documentation.
· As ambassadors to the business, Associate Director, Process Change jobholders are proactive and solution oriented - they are able to leverage on technology and proven methodologies to drive, measure and sustain process changes across the bank.
Strategy
· Implement process change initiatives while partnering with identified COO and business stakeholders to drive process change programmes aligned to our strategy, business and functional priorities and overall budgets
· Oversight of function led process change initiatives, provide advice on overall process change narrative and messaging
Business
· Understanding of Corporate Affairs, Brand and Marketing function and the value it unlocks for the organisation
· Develop understanding of the key impacted business stakeholders to identify “moments that matter” in our colleagues change journey
· Collaborate with the Change Communications team to develop and review compelling communications, strong engagements and robust training plans to drive overall adoption among our colleagues throughout the overall process change journey
Processes
· Evaluate business processes and propose process optimisations/improvements
· Write/document existing and new business processes, create clear process maps
· Drive process change in the organisation, engaging key stakeholders via communications, workshops, etc.
· Ensure that key processes are effectively managed and tracked to minimise incidents due to change
· Operationalise and embed the Bank’s ways of working – agile, accelerated, insights led and data driven execution
People & Talent
· Drive the people agenda across initiatives/system changes to ensure that our colleagues are future ready
· Support engagement activities throughout the project lifecycle to ensure high levels of connectivity and engagement
· Lead through example and build the appropriate culture and values
Risk Management
· Ensure that process change initiatives and reporting are in line with risk management frameworks
· Spot, highlight and escalate potential risk and issues according to Change governance
Governance
· Awareness and understanding of the regulatory framework, in which the Group operates, and the regulatory requirements and expectations relevant to the role
Regulatory & Business Conduct
· Display exemplary conduct and live by the Group’s Values and Code of Conduct.
· Take personal responsibility for embedding the highest standards of ethics, including regulatory and business conduct, across Standard Chartered Bank. This includes understanding and ensuring compliance with, in letter and spirit, all applicable laws, regulations, guidelines and the Group Code of Conduct.
· Effectively and collaboratively identify, escalate, mitigate and resolve risk, conduct and compliance matters.
Key stakeholders
· Corporate Affairs, Brand, and Marketing (CABM) colleagues
· CABM and COO Leadership Team
· CABM Technology Operations & Infrastructure team
· CABM Insights, Data & Analytics team
· Colleagues in CPBB & CCIB Marketing as well as in CABM regions/markets
Our Ideal Candidate
· 6+ years’ experience in a process change, business analytics role, ideally in a marketing or communications function
· Bachelor’s degree in business / related discipline
· Demonstrated experience in supporting large-scale process change in a complex organisation
· Advanced process mapping and workshop facilitation skills, using relevant tools
· Understanding or exposure to Corporate Affairs, Brand and Marketing function, and the value it unlocks for the organisation
· Ability to foster positive relationships with internal stakeholders at appropriate level, ensuring open and cooperative environment
· Ability to effectively prioritise multiple tasks in a high-pressure environment
· Experience with project management and agile delivery methodologies
· Open minded and curious with a passion for emerging trends and technologies shaping the future of Corporate Affairs, Brand & Marketing
· Systematic with high attention to details
Role Specific Technical Competencies
· Adaptive & Strategic Planning
· Business Acumen
· Change Management
· Impact Measurement
· Strategic Communications
· Partnership Management
About Standard Chartered
We're an international bank, nimble enough to act, big enough for impact. For more than 160 years, we've worked to make a positive difference for our clients, communities, and each other. We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before. If you're looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you. You can count on us to celebrate your unique talents. And we can't wait to see the talents you can bring us.
Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours. When you work with us, you'll see how we value difference and advocate inclusion. Together we:
· Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do
· Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well
· Be better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term
In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing.
· Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations
· Time-off including annual, parental/maternity (20 weeks), sabbatical (12 weeks maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum
· Flexible working options based around home and office locations, with flexible working patterns
· Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits
· A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning
· Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential.
Recruitment assessments - some of our roles use assessments to help us understand how suitable you are for the role you've applied to. If you are invited to take an assessment, this is great news. It means your application has progressed to an important stage of our recruitment process.
Visit our careers website www.sc.com/careers
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Outlined below are the required minimum qualifications for this position. If none are listed, there are no minimum qualifications.
Minimum Qualifications: Bachelor’s degree in Finance, Human Resources, Engineering, Supply Chain, or related field and 5 years’ experience in consulting, project management, business strategy, or related area OR 7 years’ experience in consulting, project management, business strategy, or related area. 2 years’ experience leading cross functional teams.Outlined below are the optional preferred qualifications for this position. If none are listed, there are no preferred qualifications.
Project Management, Strategic PlanningMasters, Masters: Human Resources, Masters: Supply ChainLean Six Sigma Champion Certification - Certification, Project Management - Project Management Professional - CertificationOfficial account of Jobstore.
The Chief has the overall responsibility for the supervision, administrative management and direction of the SPS. Ensures SPS functions are in compliance with all regulatory mandates. Forecasts, plans, develops and manages the SPS program. Manages SPS personnel and serves as liaison between SPS and other departments. Maintains effective interdepartmental relationships, coordinates and resolves problems, and ensures cooperation with other programs and services. Manages the overall SPS budget including determining resource needs, allocating resources, and ensuring proper utilization in productivity, efficiency and cost effectiveness of SPS operations. Formulates objectives, develops priorities and implements plans that support organizational goals. Ensures operations are in compliance with all safety, regulatory and accrediting requirements. Oversees orientation and training of staff. Performs other duties as assigned.
Work Schedule: Monday - Friday, 0800-1630
Compressed/Flexible:Not Available
Telework: Available
Virtual: This is not a virtual position.
Functional Statement #: 000000
Relocation/Recruitment Incentives: Not Authorized
Financial Disclosure Report: Not required
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Job Responsibilities:
• Independently carry out Design Safety Philosophy, HSE Plan and specifications for
fire protection systems (Active and Passive), HFE, etc
• Participate in Process Hazard reviews and analysis including HAZOP/HAZID/SIL
studies and responsible for actions close-out
• Lead/Chair the HAZOP/HAZID/SIL workshops, if required
• Responsible for review Third Party safety studies including FERA, Dispersion
analysis, EERA, ESSA, Dropped objects study, QRA studies, etc. (not limited too).
Capable to carry out independently similar Safety studies, as required
• Carry out independent design of Active and Passive Fire Protection systems and
prepare Hazardous/H2S Area Classification documentation, Safety and Fire Fighting
layouts, escape route and life saving equipment layout and other Safety drawings
• Carry out Safety critical elements performance standards, RAM, fire and gas
detection mapping, etc. based on project requirements
• Act as Package Engineer for Safety and fire fighting equipment
• Manage and guide Junior/Sr. Engineers and Designers on Concept/FEED/Detailed
Engineering projects
• Provide health and environmental inputs (inputs include health risk assessments
such as chemical exposure, noise and lighting, Ergonomics/Human factors
Engineering, environmental impact assessments, etc.) to projects
• Interface/Co-ordinate with other engineering disciplines, client and take lead in
resolving technical matters related to safety aspects
• Able to deliver project Safety deliverables as per project schedule
• Provide inputs and support to projects in all Safety aspects including progress
reports
Job Requirements
• Bachelor Degree in Chemical Engineering or equivalent from an accredited
university
• Minimum 22 years’ of relevant Design Engineering experience
• Have good HSE Engineering experience in the Oil and Gas industry, in Process
Safety/Technical Safety and worked minimum 3-5 years’ as a Lead position in
similar projects
• Has involvement in design projects for Offshore (FPSO/Platforms) and Onshore
(Refineries, LNG facilities, Storage terminal, etc)
• Should have worked in minimum number of Offshore projects (FPSO/Platforms)
• Possess good knowledge of Oil and Gas process facilities, local and international
Process Safety codes and standards and regulatory/marine codes and standards
(MODU, SOLAS, DNV/Lloyds Register)
• Should have hand on experience in Plot plan review, HAZID, HAZOP, SIL
classification/verification and other safety reviews (e.g. SIMOPS, ALARP)
• Good working knowledge in PIPENET Vision, Flaresim and other consequence
modelling software such as DNV PHAST etc. is needed
• Ability to influence designs to achieve optimal HSE outcomes
• A team player with leadership potential and shall have pro-active inter-discipline
communication
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