Freelancer Detail | GMDP.Expert

GMDP-0036

VP – MSAT & Head of Manufacturing

Disponible

Années d'expérience

Manufacturing / Production

Spécialisation

Tanzanie

Localisation

À propos de cet expert

Biopharmaceutical leader with 28+ years of global experience in end-to-end vaccine manufacturing, specializing in drug substance (DS) production, technology transfer, and cGMP-compliant facility design. Proven expertise in leading cross-functional teams to secure WHO prequalifications (Rabies, Typhoid Conjugate), optimize OpEx/CapEx budgets, and scale antigen production capacity. Adept at lean manufacturing, digital transformation, and strategic stakeholder collaboration to drive OTIF delivery and regulatory compliance (USFDA, EMA, WHO).

Compétences

Expert

Biologics & biosimilars Sterile manufacturing Vaccines

Avancé

GMP Auditing IQ/OQ/PQ Validation Equipment qualification Facility qualification Process validation Analytical testing Biological & Immunological Testing Packaging Stability Study Design & Execution Supplier Auditing Regulatory inspection support Regulatory Submissions Change Control Data Integrity Out-of-Specification (OOS) Investigation Cold Chain Management Method validation CAPA Management Deviation Management SOP Writing & Review Microbiological testing

Intermédiaire

Annual Product Quality Review Computer system validation

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