ROLE SUMMARYThe Manager, Drug Product Manufacturing Technical Services Lead (TSL) is responsible for the management of sterile clinical drug product manufacturing technology transfer for internal Pfizer clinical and commercial sites and external Contract Manufacturing Organizations (CMOs). The position may be located in Andover, MA, Chesterfield, MO, Durham, NC or Cambridge, UK and will directly interface with manufacturing sites, Drug Product Design and Development (DPDD) groups within Pharmaceutical R&D, QA, Analytical, Project Teams and Global Clinical Supplies (GCS). ROLE RESPONSIBILITIES
- The Tech Services Leads (TSL) manage technology transfer for BioTherapeutics clinical sterile drug product manufacturing.
- Manage Phase I and II 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.
- Develop, review, and approve technology transfer documents for manufacturing of clinical and commercial supplies.
- Oversee efforts and closely work with CMOs, QA, Analytical, Development and Supply Chain organizations to ensure timely manufacture and delivery of clinical supplies for parenteral drug products.
- Lead quality investigations and develop and implement agreed upon corrective and preventative actions.
- Represent Tech Services group on site during engineering trials and clinical manufacturing of drug product supplies at CMOs and Pfizer PGS sites.
- Liaise with formulation and process development groups to manage development of new drug product manufacturing processes for internal and external manufacturing sites.
- Lead manufacturing team discussions to ensure manufacturing readiness to meet clinical supply needs based on agreed schedules. Review and approve manufacturing batch records to ensure compliance with cGMP requirements.
- Bachelor's degree in a scientific discipline, Life Science or Engineering.
- Minimum of 5 years of direct experience in GMP manufacture or drug product development or manufacturing.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Training in cGMP compliance, parenteral process technology and knowledge of regulatory requirements for sterile drug product manufacturing is preferred.
This position will require 10% of domestic and international travel in support of manufacturing activities at CMOs or Pfizer Global Supply sites.OTHER JOB DETAILS
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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Research and Development