Pfizer Technical Associate, Clinical Manufacturing in Andover, Massachusetts

The Technical Associate, Clinical Manufacturing associate 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 in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training within the production support area.

Post facility start up, the successful candidate will transition to 2nd shift. The successful candidate will be a part of a team responsible for the execution of upstream mammalian and microbial processes.

ROLE RESPONSIBILITIES

  • Execute upstream mammalian cell culture and microbial fermentation processes in a cGMP environment. Includes CIP and SIP operations.

  • Execute product change over activities with the guidance of process engineer and tech transfer team.

  • Execution of SOP's and batch record documentation of upstream unit operations.

  • Cross-functional communication with tech transfer team, quality and engineering as necessary.

  • Cross-shift communication with 1st shift. Actively participates in shift exchange activities and communication channels.

  • Active participant of the OWN IT culture. Identifies and supports continuous improvement initiatives. Utilizes continuous improvement and root cause analysis tools ( 5S and DMAIC)

  • Maintains a safe work environment.

  • Effectively uses process automation systems (i.e. Delta V and OSI/Pi Historian) and supporting business systems (i.e. Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc.)

BASIC QUALIFICATIONS

  • HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent.

  • Requires a minimum 0-3 years of experience in a biotechnology manufacturing or laboratory environment.

PREFERRED QUALIFICATIONS

  • Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting

  • Knowledge of mammalian cell culture and/or microbial fermentation processes.

  • Familiarity with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)

  • Ability to follow Standard Operating Procedures and work under minimal supervision.

  • Fundamental mechanical aptitude and ability to interface with computerized systems required.

  • Demonstrated capability to work as a team member in a matrix manufacturing team.

  • Excellent oral and written communication skills.

PHYSICAL/MENTAL REQUIREMENTS

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

  • Must be able to lift up to 25lb

  • Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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

  • Ability to work in a clean room environment

Other Job Details:

  • Last Date to Apply for Job: July 25, 2018

  • Additional Location Information: Andover, MA

  • Eligible for Employee Referral Bonus: Yes

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

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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.