Summary
Cutting-edge Biotech focused on advancing precise and innovative novel therapies in the greater bay area is searching for a passionate and creative scientific leader to oversee the Drug Product Development scale-ups on their CMC team. They will take on break through innovation while collaborating to solve key challenges leading their team to success!
Responsibilities
- Lead the Formulation team to develop the drug product development of small molecule programs to commercialization
- Lead the oversight of daily activity to ensure CGMP compliance
- Interpret raw data, organize results/ create reports, and communicate findings
- Overseeing tech transfers, scale ups and outsourced formulations
- Communicate findings to project teams and management
Qualifications
- M.S/Ph.D./ in Pharmaceutical Sciences (or a related scientific field) or BS +15 Years experience
- Experience authoring CMC sections for IND, IMPD,CTA/NDA (Preferred)
- Experienced in overseeing outsourced vendors (CROs/CM Os/CTLs/CDMOs) - highly coveted
- Strong hands-on experience in Drug Product/Formulations
- Experience in late-stage small molecule solid oral dosage forms
- Effective and concise communication/decision making skills
Benefits
- Competitive
