Vice President, Drug Product

$279,200 - $300,000/Yr

Bayside Solutions - Santa Clara, CA

Full-time - Executive

Santa Clara, CA

Sporting Goods, Hobby, Musical Instrument, Book, and Miscellaneous Retailers

About the position

The Vice President of Drug Product is responsible for overseeing formulation development and drug product manufacturing operations, ensuring the successful clinical development and commercialization of pipeline compounds. This role involves providing technical, organizational, and strategic leadership while collaborating with cross-functional teams to execute drug product development and manufacturing in alignment with development plans and timelines. The position also plays a crucial role in shaping the overall CMC strategy.

Responsibilities

• Lead formulation development and drug product manufacturing operations from early to late development through commercialization.
• Oversee execution of functional activities associated with formulation development and drug product manufacturing in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
• Author, review, and approve the relevant CMC sections to enable global regulatory filings.
• Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies.
• Serve as a project core team member, communicating CMC strategy and project status to key stakeholders cross-functionally and assisting in driving decision-making.
• Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, tox, and program management) to ensure CMC and program goals are met.
• Lead the efforts to assess and identify potential drug product development and manufacturing suppliers with adequate risk assessment.
• Travel to CDMOs for vendor assessment and qualification and manufacturing oversight as needed.

Requirements

• 18+ years of experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase formulation development, and drug product manufacturing experience of small molecules.
• Extensive experience in late-phase drug product development and commercial launch with global CMC regulatory filings (IND/NDA/MAA).
• 10+ years of strategic leadership and management experience.
• Demonstrated project, cross-functional team leadership, and people management skills.
• Thorough understanding and working experience in drug product development and manufacturing concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
• Extensive working experience with management and oversight of the manufacturing activities at CDMOs.
• Strong problem-solving skills with strategic and sound technically driven decision-making ability.
• Effective written and verbal communication skills and interpersonal skills.
• Innovative team player with high energy for our dynamic company environment.
• A PhD (minimum MSc) in Pharmaceutics, Chemistry, Chemical Engineering, or a closely related field is preferred.

Nice-to-haves

• Drug product development
• Formulation development
• Drug product manufacturing
• Small molecule
• Late-phase
• CMC regulatory filing
• ICH guidelines
• FDA
• EMA
• GMP
• Pharmaceutics
• Chemistry
• Chemical engineering