Pfizer

Senior Lead Investigator, ACMF

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Posted
November 24 2021
Ref
4830479
Discipline
Other, Other
Position Type
Full Time
Organization Type
Pharma
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 ACMF Investigation team was established in Q4 2020. The Senior Lead Investigator will work with Quality Assurance, ACMF Operations, Tech Transfer, and other stakeholders to lead and author investigations. This position and team are in Andover, MA and may remotely support other Pfizer sites as needed. The Senior Lead Investigator will report to the Investigations Manager

ROLE RESPONSIBILITIES
  • Author manufacturing investigations within ACMF quality system
  • Lead cross-functional root cause analysis and corrective action/preventive action (CAPA) planning
  • Author and manage Change Controls for ACMF Operations
  • Manage investigation timelines against product dispositions
  • Support audits as needed
  • Support other ACMF documentation needs as needed on a non-routine basis (CAS assessments, audit responses, etc.)


BASIC QUALIFICATIONS
  • Bachelor's degree in a biological or engineering discipline with 5+ years of experience
  • Advanced technical writing skills
  • Proficient in Microsoft Word
  • Ability to self-manage timelines and deliverables
  • Excellent written and verbal communication
  • Strong organizational skills with demonstrated attention to detail
  • Ability to thrive in a dynamic environment


PREFERRED QUALIFICATIONS
  • Prior experience writing cGMP manufacturing investigations
  • Advanced understanding of bioprocessing techniques, equipment, and knowledgeable in various manufacturing disciplines such as buffer/media preparation, mammalian or fermentation upstream processing, and downstream purification techniques
  • 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
  • Strong technical aptitude and problem-solving skills
  • Thorough knowledge of industry practice and cGMP regulations


PHYSICAL/MENTAL REQUIREMENTS
  • Ability to gown into a clean room environment


Other Job Details:
  • Last Date to Apply: November 30, 2021
  • Eligible for Relocation Package: Yes
  • Eligible for Employee Referral Bonus: Yes


#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Research and Development

#LI-PFE

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