Senior Director

Job Description : Senior Director, Product Development/Small Molecule/Solid Dose Drug Product Development/technical operations/Commercial for an exciting pharmaceutical company in California. Role is open to suitably qualified candidates worldwide Playing a critical role for POST-LAUNCH, overseeing the production/ MANUFACTURING/COMMERCIALIZATION activities of solid oral dosage tablets products, including formulation, granulation, compression, coating, packaging, and testing. Must have a strong understanding of FDA and other regulatory requirements for pharmaceutical manufacturing and the ability to troubleshoot complex manufacturing issues. Strong leadership and management experience in late-stage product development, scale-up, tech transfer and process optimization of solid oral dosage formulations with extensive experience in late-phase drug product development and commercial development with CMC regulatory filings. Required: 18-28 years in industry, BS/MS or Ph.D; experience with NCEs and NDA regulatory filings (no generics); • . Excellent relocation package if needed. MUST HAVEs: NCE background Manufacturing of solid orals Commercialization of solid orals in NCE

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