Associate Director, Chemical Development

CMC Brisbane, California


Description

The Associate Director, Chemical Development reporting to the Director of Chemical Development, Manufacturing and Technical Operations will be responsible to lead technology transfer, process development, and manufacturing efforts of MyoKardia compounds at contract manufacturing organizations (CMOs).  He/she will work closely with Formulation and Analytical Development, Quality, and Supply Chain to establish drug substance GMP manufacturing processes and ensure timely delivery of quality materials for clinical programs at MyoKardia.  The ideal candidate will have solid understanding of Manufacturing, Supply Chain, Analytical Development, Formulation Development, CMC Regulatory and Quality Assurance.

Essential duties and responsibilities include but are not limited to the following:

  • Lead and oversee API development and manufacturing activities at CMOs including vendor selection and qualification, process transfer, and GMP manufacturing
  • Lead phase appropriate process development, optimization, and scale up studies to facilitate activities at CMOs
  • Participate in cross-functional CMC activities as a representative of Process Chemistry/Chemical Development
  • Perform technical review and approval of batch records, reports and other technical and quality documents
  • Partner with Formulation and Analytical Development to understand and characterize the physical and chemical properties of compounds
  • Partner with Formulation and Analytical Chemistry, Quality, and Supply Chain to ensure drug substances are delivered on time and within specification
  • Write and review CMC sections of regulatory filings when needed
  • Keep abreast of all relevant publications and guidance documents

Position Requirements and Experience:

  • A demonstrated track record of delivering results with high integrity, quality focus and collaboration
  • A Ph.D. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field with at least 10 years (or M.S. with >15 years) of relevant experience in the biotech/pharmaceutical industry
  • Expert knowledge of process chemistry, contract GMP manufacturing, analytical methods and physical-chemical characterization methods
  • Demonstrated leadership skills to oversee GMP contract manufacturing organizations
  • Proven ability to develop, optimize and scale up drug substance manufacturing processes
  • Experience with IND/IMPD is required, and NDA/MAA submission experience highly desirable
  • Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders
  • Excellent organizational skills, with ability to successfully manage multiple priorities
  • Work effectively with cross-functional teams
  • Highly self-motivated and detail-oriented, with proven ability to work independently