Pfizer Manager, Downstream Clinical Manufacturing (1st Shift) in Andover, Massachusetts

The Downstream Clinical Manufacturing area manager is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

Initial focus is on the start up of a new facility with accountability to ensure compliance with Pfizer specifications during the facility/equipment commissioning and qualification, and the creation of all necessary cGMP documentation.

Post facility start up, the successful candidate will lead a team of 7-10 colleagues responsible for the operation, troubleshooting, and data analysis of downstream biologics processes.


  • Responsible for in plant manufacturing operations to ensure the on time delivery of high quality drug substance for clinical use.

  • Direct reporting and career development responsibility for a team of 7-10 engineers and/or technicians.

  • Lead troubleshooting of manufacturing equipment and control systems. May perform operations as needed.

  • Perform on the floor commissioning and startup of operations equipment

  • Lead/Support the design and qualification of improvements, changes, or upgrades to this equipment as needed

  • Strong bioprocess knowledge required to provide guidance or direction for team and effectively communicate and/or escalate process related issues.

  • Coordination of team activities and scheduling of operations with other area managers.

  • Cross functional collaboration with BRD lab scientists, Quality Unit, site and network manufacturing facilities, and Engineering on interdepartmental and cross site initiatives.

  • Lead tech transfer activities for new products and product changeovers.

  • Support all investigations and audits as needed.

  • Provide off-shift and on call support when necessary.

  • The manager will provide oversight to direct reports, and interact with a cross-functional team including engineering, quality, supply chain, and Bioprocess R&D Development Labs.


  • BS or MS in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent) with 8+ years experience in biologics process development, technology transfer, pilot or manufacturing required. Understanding of downstream processes is strongly desired.

  • Demonstrated capability to work across functional areas such as development, maintenance, quality and regulatory.

  • Good communication skills, verbal and written, are required.

  • Experience in a cGMP environment with increasing responsibility is desired . Management experience is also highly desirable.

  • Working knowledge of automated production systems with ability to manipulate and troubleshoot systems.


  • Ability to work off shift (Nights and Weekends) as needed; non-routine

  • Ability to work in a clean room environment


  • Last Date to Apply for Job: August 31, 2018

  • Additional Location Information: Andover, MA

  • Eligible for Relocation Package: Yes

  • Eligible for Employee Referral Bonus: Yes

EEO & Employment Eligibility

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.