Job Description

ROLE SUMMARY

The Andover Clinical Manufacturing Facility (ACMF) is located on the Pfizer Andover, MA campus and is responsible for the cGMP manufacture of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

The Investigations Associate is a new position in the ACMF. Manufacturing investigations are currently written by the ACMF Operations staff. A dedicated Investigations team is being created and will be part of the ACMF Tech Transfer team.

ROLE RESPONSIBILITIES

* Author manufacturing investigations within ACMF quality system
* Author and manage Change Controls for ACMF Operations
* Support audits as needed
* Support other ACMF documentation needs as needed on a non-routine basis (CAS assessments, audit responses, etc.)

BASIC QUALIFICATIONS

* BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent with 0-3 years of experience in the pharmaceutical industry.
* Advanced technical writing skills
* Proficient in Microsoft Word
* Ability to self-manage timelines and deliverables
* Advanced interview skills

PREFERRED QUALIFICATIONS

* Prior experience writing cGMP manufacturing investigations
* Basic understanding of bioprocessing techniques and equipment
* Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS , etc.)
* Demonstrated capability to assemble a matrix cross-functional team

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

* Ability to work in a clean room environment

Other Job Details:

* Last Date to Apply for Job: January, 18, 2021
* Eligible for Employee Referral Bonus: YES

LI-PFE

Sunshine Act

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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.

Research and Development

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