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Senior Manager, Drug Product Manufacturing (mRNA)

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Closing date
Oct 6, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Position Type
Full Time
Job Type
Manager
Organization Type
All Industry, Pharma
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ROLE SUMMARY

The Senior Manager, Drug Product Manufacturing (mRNA) is responsible for leading a group of Technical Services Leads (TSLs) within the PhRD Clinical Manufacturing Technical Services Group responsible for advancing early phase mRNA portfolio. This position reports to the Director of Clinical Manufacturing Technical Services Group.

ROLE RESPONSIBILITIES
  • Project Lead and Pharmaceutical R&D representative for mRNA early phase drug product manufacturing project teams.
  • Supervise and manage Tech Services Leads responsible for technology transfer for mRNA clinical drug product manufacturing.
  • Work closely with Technical Services mRNA Portfolio and Project Lead and Operations Manager to manage resources and project assignments and strategic direction.
  • Mentor direct reports and others in the group in technical aspects of mRNA GMP and sterile drug product manufacturing.
  • Manage select complex sterile vial and pre-filled syringe drug product clinical manufacturing at internal clinical manufacturing sites and Contract Manufacturing Organizations (CMOs).
  • Manage and support Phase III and commercial launch sterile drug product manufacturing at Pfizer commercial sites in the US and Europe.
  • Work with Portfolio Project Leads to develop, review, and approve technology transfer documents for manufacturing of clinical and commercial supplies.
  • About 10 % domestic and international travel will be required in support of manufacturing activities at CMOs or Pfizer Global Supply sites.


BASIC QUALIFICATIONS
  • Bachelor's degree in a scientific discipline, Life Science or Engineering.
  • Minimum of 7 years of direct experience in GMP manufacture or drug product development or manufacturing.

PREFERRED QUALIFICATIONS
  • Master's degree in a technical or managerial field.
  • Experience with mRNA technologies including LNP manufacturing.
  • Training in cGMP compliance, parenteral process technology and knowledge of regulatory requirements for sterile drug product manufacturing is preferred.
  • Experience with supervising direct reports in a matrix organization.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This position will require 10% of travel including visiting international sites.

Other Job Details

Relocation Support Available
Work Location Assignment:Flexible

Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.

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Relocation assistance may be available based on business needs and/or eligibility.

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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

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