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.
NON-STANDARD WORK REQUIREMENTS
Ability to work off shift (Nights and Weekends) as needed; non-routine
Ability to work in a clean room environment
ADDITIONAL OFFER DETAILS
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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