The PhRD Clinical Manufacturing Technical Services Group (TSG) Director will lead a team with responsibility for management of sterile clinical drug product manufacturing and technology transfer for internal Pfizer and external Contract Manufacturing Organizations (CMOs). The position is located in Andover MA and will directly interface with FPD (Formulation and Process Development) group within Pharmaceutical Research and Development (PhRD), Quality Assurance (QA), Analytical, project teams Pfizer Global Supply (PGS) Manufacturing and Global Clinical Supplies (GCS). The TSG Director will establish strategy and objectives for multiple high complexity projects working in conjunction with PhRD and stakeholder leadership.
Lead a dynamic group to most effectively manage Phase I and II sterile vial and pre-filled syringe drug product clinical manufacturing at multiple Contract Manufacturing Organizations (CMOs) as well as Phase III and commercial launch sterile drug product manufacturing at Pfizer commercial sites in the US and Europe.
Establish and implement strategy to support manufacturing of evolving and complex portfolio.
Closely work with formulation and process development leadership to direct development of new drug product manufacturing processes for internal and external manufacturing sites.
Develops solutions to problems impeding the ability to transfer technology or support manufacturing and implements appropriate change.
Leads by example closely working with CMOs, QA, Analytical, Formulation and Supply Chain organizations to ensure timely manufacture and delivery of clinical supplies for parenteral drug products.
Lead manufacturing team discussions to ensure manufacturing readiness to meet clinical supply needs based on agreed schedules
Represent Tech Services group on site during engineering trials and clinical manufacturing of drug product supplies at CMOs and Pfizer PGS sites.
Minimum BS required, degree in a scientific discipline, Life Science or Engineering is preferred.
Minimum of 15 years drug product experience in the biopharmaceutical industry
Must have knowledge of biologics manufacturing with a strong focus on drug product and aseptic processing
Must have knowledge of applicable Quality and Regulatory guidelines
Must have strong decision-making, leadership, interpersonal skills and the ability to communicate effectively with external partners, peers, and senior management
Must work well in cross-functional teams
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EEO & Employment Eligibility
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Other Job Details
Eligible for Relocation Package: yes
N (Other) (United States of America)
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