Senior Scientist, Process Chemistry

CMC South San Francisco, California


Description

SUMMARY:

The Senior Scientist, Process Chemistry, reporting to the Executive Director of Manufacturing and Technical Operations will be responsible for executing in-house process chemistry efforts at MyoKardia as well as manage process chemistry efforts at contract manufacturing organizations and partner facilities. This individual will work with Medicinal Chemistry to evaluate synthetic routes for late stage Discovery projects to facilitate smooth scale up for supply of compounds for pre-clinical and clinical studies. He/she will also work closely with Formulation and Analytical Development to define key attributes of our molecules and processes (e.g. specifications, IPCs, stability, etc.) and with Manufacturing to help deliver clinical supplies for all 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: 

  • Execute in-house process development and optimization studies to facilitate scale up and transfer to CMOs
  • Manage process chemistry work with CMOs from initiating process transfer, through scale up, GMP manufacturing and process validation activities
  • Collaborate with CMOs and partners to source appropriate starting materials, radiolabeled and stable isotope analogs, and other materials as needed
  • Work with discovery teams to evaluate synthetic routes and test alternatives that facilitate scale up of both target compounds and building blocks while providing insights for selection of development candidates
  • Prepare technical packages for transfer of processes to CMO or partner facilities
  • Partner with Formulation Development and Analytical Chemistry to characterize the physical and chemical properties of compounds of interest
  • Provide technical support to QA for vendor qualification and auditing
  • Technical review and approval of master batch records and executed batch records
  • Partner with Manufacturing, Formulation Development, Analytical Chemistry, Quality Control and Quality Assurance to ensure drug substances are delivered on time and within specification
  • Write and review CMC sections of regulatory filings
  • Keep abreast of all relevant publications and guidance documents

EDUCATION/EXPERIENCE/SKILLS:

  • 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 5 years (M.S. with 8 years or B.S. with 10 years) of relevant experience in the biotech/pharmaceutical industry
  • Expert knowledge of process chemistry, synthetic organic chemistry, analytical methods (especially NMR, MS and HPLC) and physical-chemical characterization of compounds
  • Proven ability to develop, optimize and scale up drug substance manufacturing processes
  • Demonstrated skills needed to manage GMP contract manufacturing organizations
  • Experience with QbD, including design of experiments preferred.
  • Late stage process development, validation and Regulatory (NDA) submission experience preferred
  • Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders
  • Excellent oral and written communications skills
  • Excellent organizational skills, with ability to successfully manage multiple priorities
  • Ability to work effectively with cross-functional teams
  • Highly self-motivated and detail-oriented, with proven ability to work independently
  • Highly proficient in MS Office Suite software (Word, Excel, MS Project, PowerPoint)