What are the responsibilities and job description for the Vice President, Drug Product position at Bayside Solutions?
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 :
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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
Salary : $279,200 - $300,000
