Team Lead - GMP Manufacturing

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Team Lead - GMP Manufacturing is a position within the St. Louis Clinical Manufacturing Facility (SCMF) organization responsible for on the floor leadership and functional management for all areas of operation within the SCMF space.  The SCMF is responsible for manufacture of clinical starting materials and Drug Substance derived from microbial and mammalian culture processes.

This position leads technical operations within SCMF during the 3rd shift and will work closely with other members of the SCMF Manufacturing ELT to ensure timely delivery of supply and process scale up commitments.

This position is responsible for identifying operational efficiency improvements and planning and implementing those improvements within the operational area.  Must be capable of implementing change to the manufacturing infrastructure to ensure area operational success.  Responsible for coaching and developing staff, identifying growth opportunities and mentoring so that all staff can realize their full potential.

How You Will Achieve It

• Accountable for operational deliverables across SCMF GMP manufacturing.

• Works across areas to integrate manufacturing activities to meet demanding development timelines and objectives and works with other area leaders to ensure that high quality, timely, and achievable project objectives are established and communicated.

• Provides a mature and experienced operations perspective for multiple unit operations supporting clinical manufacturing and process scale up approaches.

• Broad general knowledge of all unit operations performed in the manufacturing facility.

• Ability to guide junior engineers and technicians to make correct decisions during the course of daily operations.

• Sets departmental standards that encourage self-motivation and flawless execution with the goal of continuous improvement.

• Responsible for planning and developing staff, identifying growth opportunities and mentoring so that all staff can realize their full potential, as well as addressing performance issues appropriately.

• Works with the SCMF Operations group to support investigations, validations, and GMP documentation requirements as needed.

• Interacts with the Quality Assurance group on a regular basis to ensure adherence to Pfizer standards of GMP manufacturing

BASIC QUALIFICATIONS

Must Have

• B.S./M.S. in Chemical/Biochemical Engineering, or Cell Biology, Biochemistry, Microbiology and 3+ years of industry experience.

• Extensive practical knowledge in a wide variety of heterologous expression systems with a focus on E. coli and CHO cells - OR - Experience executing relevant recovery and purification processes derived from microbial and/or mammalian production cultures.

• 2+ years of demonstrated supervision/leadership of operations staff.

• 3+ years of GMP manufacturing experience.

• Excellent oral and written communication skills.

Nice to Have

• Direct or matrix management and project management training/experience.

• Experience in supporting the scale-up and tech transfer from development laboratory to clinical manufacturing.

  
PHYSICAL/MENTAL REQUIREMENTS

• Must be able to lift 40 lbs and work in a clean room environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• 3rd Shift Schedule (11:30 PM - 8 AM) - may also work 10-hour days 4 days a week

  
 

PHYSICAL/MENTAL REQUIREMENTS

Must be able to lift 40 lbs and work for extended periods without sitting.

Other Job Details

• Last day to apply: November 6, 2024.
• Work Location Assignment: On Premise.

The annual base salary for this position ranges from $88,300.00 to $147,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of li