Manager, Process Operations

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 different 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 Manager Process Operations will support the NGB Operations Leadership team reporting to the Associate Director of Production Operations.

Job Responsibilities:

• Lead a team executing upstream and downstream production operations.

• Assign daily work and ensure effective execution accountability and compliance.

• Drive cGMP and EHS compliance and promote a strong safety culture.

• Maintain a strong floor presence during GMP operations and support critical tasks as needed.

• Ensure team qualification training completion and MyLearning compliance.

• Support operational readiness activities for launch of the new GMP facility.

• Participate in interviews and hiring activities as needed.

• Coach and develop direct reports through regular 1:1s feedback and performance reviews.

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

• Review documentation in real time to support timely lot release.

• Troubleshoot technical and process issues and make timely operational decisions.

• Initiate deviations perform initial impact assessments and support investigations.

• Author revise and approve SOPs batch records work instructions and memos.

• Provide off-hours weekend holiday and on-call support as needed.

• Support start-up activities including equipment qualification training curricula staff training and MES implementation.

• Oversee production planning and associated activities.

• Partner cross-functionally to support operational readiness for tech transfer programs including product-specific planning and quality risk assessments.

• Collaborate across the network to share best practices and promote operational consistency.

Required Education Experience and Skills:

Education:

• Bachelors degree in chemical/biochemical engineering pharmaceutical sciences chemistry biochemistry biology microbiology or related discipline with minimum of 5 years relevant experience or a Masters degree with minimum 3 years of relevant experience.

Experience & Skills:

• Minimum 5 years of experience in a GMP-regulated biologics drug substance manufacturing environment preferably with single-use systems.

• Prior experience leading operations teams and monitoring performance.

• Strong understanding of GMP manufacturing environments including upstream and downstream processing.

• Working knowledge of cGMP Quality Systems and EHS requirements.

• Ability to train employees in technical compliance safety and environmental procedures.

• Experience writing SOPs and technical documents.

• Working knowledge of DeltaV MES and SAP.

• Strong troubleshooting decision-making and attention to detail skills.

• Demonstrated initiative and ability to work effectively in a fast-paced environment.

Preferred Experience and Skills:

• Experience with facility fit assessments new product introduction process transfer to/from clinical sites and clinical manufacturing.

• Experience with Veeva Quality Docs.

• Lean manufacturing and root cause analysis experience.

• Background in process engineering upstream/downstream technical support or biologics/vaccine manufacturing operations.

• Demonstrated ability to drive improvements and inspire others.

• Ability to use tools such as JMP Microsoft Office and project management software.

• Strong organizational planning communication leadership and presentation skills.

• Continuous improvement mindset and willingness to challenge the status quo.

• Ability to lift up to 25 lbs if required.

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.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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