Manufacturing Team Leader

ROLE SUMMARY

The Team Lead, Clinical Manufacturing is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance and drug product supporting the Pfizer Biotherapeutics portfolio. The position is located in Chapel Hill, NC.

The Team Lead, Clinical Manufacturing will manage a team of 5-7 colleagues responsible for the operation, troubleshooting, and data analysis of microbial fermentation and purification processes. This role is 1st shift.

ROLE RESPONSIBILITIES

• Manage production support operations and process technology transfer within their assigned operational area (e.g. upstream, downstream, production, fermentation) which includes the process, people, equipment, and documents, to ensure safe and quality drug substance and drug product is produced to support clinical trials.
  
• Manages a team of 5-7 Engineers and/or Technicians. Recruits and retains qualified, dedicated colleagues; promotes a collaborative culture that aligns with corporate culture; Grows, develops and establishes a cohesive team that is inspired, engaged and has key competencies needed.
  
• Creates and acts on succession plan.
  
• Handles troubleshooting of manufacturing equipment and control systems within assigned operational area.
  
• May perform operations as needed.
  
• Coordinates and oversees the design and qualification of new equipment or system improvements, changes, or upgrades within assigned operational area.
  
• Provides guidance or direction for team and effectively communicate and/or escalate process related issues for assigned operational area.
  
• Coordinates weekly production operations schedule for assigned operational area to ensure trained colleagues, documents and equipment are available to meet production deliverables.
  
• Cross functional collaboration with Quality Unit and Engineering for assigned operational area.
  
• Manages product changeover activities within assigned operational area.
  
• Supports all investigations and audits within assigned operational area as needed.
  
• Provide off-shift and on call support within assigned operational area when necessary.
  

BASIC QUALIFICATIONS

• Bachelor's degree in a biological or engineering discipline +5 years of experience; Associates degree or completion of 2 years of undergraduate work + 7 years of experience; or HS diploma + 9 years of experience in a cGMP Clinical, Commercial Manufacturing, and/or non-cGMP Pilot Manufacturing setting with in depth expertise of common biotechnology processes and/or API small molecule processes including mammalian cell culture, associated purification steps, and drug product/drug substance manufacturing.
  
• A minimum of 6 months year of people management, matrix leadership or project leadership experience.
  
• Understanding of upstream/downstream cell culture and/or fermentation.
  
• Proven ability to troubleshoot complex processing issues and ability to make decisions with minimal guidance required.
  
• Strong verbal and written communication skills.
  
• Experienced with electronic systems including QTS (i.e. Trackwise), Documentation, LIMS, ERP (i.e. SAP/Axis 360), Building automation system, MMS/Maintenance, Process Automation systems (i.e. Delta V, Unicorn, Finesse), and other business systems (Microsoft Word, Excel, etc.).
  
• Proven ability to make risk-based decisions in a complex/dynamic environment in a timely manner.
  
• Experienced in authoring cGMP documentation including SOPs and Batch records.
  
• Working knowledge of validation documents such as P&IDs, URSs, FRSs, and qualification protocols/reports (Chapel Hill only).
  
• Able to work functional areas such as quality and engineering in matrix environment.
  
• Ability to flex and quickly adapt to changing environment and competing priorities.
  

PREFERRED QUALIFICATIONS

• Working knowledge of validation documents such as P&IDs, URSs, FRSs, and qualification protocols/reports (Andover only).
  

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to climb flights of stairs and be standing for ~1-2 hours at a time.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• This position is a 1st shift position.
• Ability to work off shift (Nights and Weekends) as needed; non-routine.
• Ability to work in a clean room environment.

Other Job Details:

• Last Date to Apply for Job: December 2, 2020
• Eligible for Employee Referral Bonus
• Eligible for Relocation Package

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Manufacturing