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Pfizer Tech Associate, Clin Manufacturing, Upstream (2nd Shift) in Andover, Massachusetts

ROLE SUMMARY

The clinical manufacturing Technical Associate is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

Creation and revising of necessary cGMP documentation, and training within the production manufacturing area.

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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This is a 2nd shift position (3-11:30p)

  • Ability to work occasional weekends as needed; non-routine

  • Ability to work in a clean room environment

ADDITIONAL OFFER DETAILS

  • Last Day to Apply: November 20, 2019

  • Additional Location Information: Andover, MA

  • Eligible for Employee Referral Bonus: Yes

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

#LI-PFE

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

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