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.
- 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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 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.
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.
Relocation assistance may be available based on business needs and/or eligibility.
\nPfizer 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
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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