Associate Director, Process Operations Lead

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Companys biologics pipeline. We work closely with colleagues in Discovery Pre-clinical and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility which will be a premier state-of-the-art facility that is a key part of our Chemistry Manufacturing and Controls (CMC) hub at our site headquarters in Rahway NJ. This facility will be fully online in the next few years both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites which can adjust as the clinical pipeline demands change. It can meet all historic currently existing and cutting-edge biologics program demands from supporting development to pilot scale small and large scale potent material handling and the ability to integrate new technologies and cell-line platforms.

The Associate Director Process Operations Lead will be a member of the NGB Operations Leadership team reporting to the Head of Production Operations.

Job Responsibilities:

• Strategic member of the capital project delivery project team providing Operational knowledge & leading efforts in Operational Readiness to deliver and stand up a new GMP clinical facility.

• Lead a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical campaigns.

• Oversee the coordination efforts for Drug Substance Manufacturing Execution (Shop Floor Operations) intended to meet the requirements of New Product Introduction (NPI) schedule.

• Manage the Operations team which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies.

• Drive operational excellence for Right First Time (RFT) batch execution.

• Oversee production planning and associated activities integrated with the NGB Multiproduct platform.

• Ensure 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 GMP systems in support of operations. Develop future breakthrough business solutions initially leveraging existing resources in the companys network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.

• Collaborate 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.

Required Education Experience and Skills:

Education:

• Bachelors degree in chemical/biochemical engineering pharmaceutical sciences chemistry biochemistry biology microbiology or related discipline with minimum of 8 years relevant experience or a Masters degree with minimum 6 years of relevant experience or a PhD degree with minimum 3 years of relevant experience.

Experience & Skills:

• Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment ideally with experience of single-use systems.

• Prior experience of operations team management and monitoring performance.

• Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing.

• Strong working knowledge of cGMP Quality Systems (problem deviations change management etc.) Safety for operations.

• Experience with facility fit assessments New Product Introduction transfer of processes to and from clinical site and clinical manufacturing experience.

• Delta V and MES (Manufacturing Execution System) knowledge and experience

• Ability to perform technical analysis using software such as JMP efficiency in Microsoft office project management (plus) communication.

Preferred Experience and Skills:

• Experience in Lean Manufacturing & Root Cause Analysis

• Previous experience in process engineering upstream and/or downstream technical support or manufacturing operations for biologics and/or vaccine products.

• Experience with operationalization of GMP operations and/or large facility builds or renovations as well as ability to work in a fast-paced environment.

• Proven self-motivation ability to drive improvements and inspire others.

• Demonstrated ability to work effectively as part of diverse teams.

• Strong problem-solving skills and the ability to overcome technical and organizational challenges.

• Excellent attention to detail highly independent with initiative.

• Excellent troubleshooting and problem-solving skills.

• Ability to challenge the status quo with a continuous improvement mindset.

• Strong leadership ability and collaborative skills.

• Strong analytical and presentation skills.

• Ability to lift 25 lbs if required.

PRD

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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