Total 3 Director/C-Level Operations Supervisor job vacancies in The United States of America

Job Description

A fantastic and hugely exciting opportunity has arisen for an Operations Director/Integrated Process Team (IPT) Lead. Reporting to the Site Operations Lead, this position will drive operational excellence to deliver all components of a stable manufacturing team and process for Biologics clinical and commercial manufacturing at our new single-use commercialization facility. This position will provide leadership and operations support on Biologics drug substance (DS) manufacturing in addition to technical transfer, PPQ and approval of new products in the future.

Bring energy, knowledge, innovation to carry out the following:

·       Responsible for Downstream Operations within a state of the art multi-product facility used for clinical and commercial manufacture of Biologics Drug Substance.

·       Plans and directs all aspects of production activities associated with manufacturing or technology transfer and ensures that all projects, initiatives and processes are in conformance with our company's established policies, standards and objectives.

·       Serve on the Site Leadership Team to develop and deliver toward site and organizational priorities and strategy.

·       Ensure right-first-time and stable start-up, including through technology transfer leadership, execution of clinical, PPQ and commercial batches, change management and implementation of process improvements.

·       Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, and adherence to all regulatory expectations.

·       Ownership for ensuring permanent inspection readiness is in place.

·       Ensure production and project milestones are achieved through planning and execution of integrated overall program schedule

·       Establish and deliver on KPI’s in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure.

·       Drive execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model. 

·       Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to succeed in manufacture.

·       Resolve resource and prioritisation constraints and support resource needs and changes. 

·       Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes.

·       Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders.

·       Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process.

·       Provide clear direction and definition of any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis

·       Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site Stakeholders.

·       Manage financial forecasts and workload to achieve departmental headcount and cost improvements.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

General competencies:

·       Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high performance organizational culture that accommodates rapid growth & highly dynamic operating execution.

·       The desire to continuously learn, improve and grow, and cultivate continued development within the team

·       Innovative thinker, with excellent decision-making and problem-solving skills.

·       Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of our company's site in Dunboyne.

·       Ability to influence across organizational layers, as well as outside the site and externally with partners.

·        Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives.

·       A great communicator, decisive decision maker with a proven ability to deliver excellence.

Technical competencies:

·       Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean Methodologies and a proven track-record in project management.

·       Proven capabilities and knowledge of Biologics Drug Substance manufacturing, parti
cularly in downstream processes

·       Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.

·       Knowledge of global and company health authority regulations and applicable systems & GMP requirements.  Experience engaging with regulatory agencies including in on-site inspections

·       Sound judgment and comfortable operating in a challenging, fast-paced and sometimes ambiguous environment.

Minimum Education/Experience:

·       Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies).

·       Demonstrated leadership with at least 5 years leading in a cross-functional environment, including indirect or direct people management experience·       Demonstrated biotech/vaccines/pharma manufacturing site, project or other relevant experience

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):