Vice President, Drug Product

Direct Hire Full-Time Role

Salary Range: $279,200 - $300,000 per year

Location: San Mateo County, CA - Hybrid Role

Job Summary:

You will be accountable for formulation development and drug product manufacturing operations, supporting the clinical development and commercialization of our pipeline compounds. You will provide technical, organizational, and strategic oversight, collaborating closely with cross-functional teams to ensure seamless execution of drug product development and manufacturing following our development plan and program timelines. Additionally, you will play a vital role in shaping and executing the overall CMC strategy.

Duties and Responsibilities:

• Lead formulation development and drug product manufacturing operations from early to late development through commercialization.
• Be responsible for development strategies, overseeing 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 and Qualifications:

• 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
• 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.

Desired Skills and Experience

Drug product development, formulation development, drug product manufacturing, small molecule, late-phase, CMC regulatory filing, ICH guidelines, FDA, EMA, GMP, pharmaceutics, chemistry, chemical engineering

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at