Senior Scientist, Small-Molecule Drug Substance Development
- This newly created position reporting to the Associate Director of Drug Substance Development will help manage process chemistry and GMP manufacturing efforts at contract manufacturing organizations and the sourcing of related raw materials and intermediates.
- She/He will manage process chemistry work at CMOs from initiating process transfer, through scale up, GMP manufacturing and process validation activities.
- She/He will prepare technical packages for transfer of processes to CMO or partner facilities.
- She/He will participate in building Arcus's process chemistry capabilities and work with Medicinal Chemistry to evaluate synthetic routes utilized for late-stage Discovery projects.
- She/He will also work closely with Formulation and Analytical Development to define key attributes of our molecules and GMP manufacturing processes (e.g. solid forms, specifications, IPCs, stability, etc.) and with Supply Chain to ensure timely delivery of clinical supplies for all programs.
- She/He will provide technical review / approval of master / executed batch records.
- She/He will partner with Manufacturing, Formulation Development, Analytical Chemistry, Quality Control and Quality Assurance to help ensure Arcus' manufactured GMP drug substances are delivered on time with appropriate quality.
- She/He will contribute to writing / reviewing CMC sections of regulatory filings as needed.
- Ph.D. in Organic Chemistry.
- 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 (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 and RSM contract manufacturing organizations.
- Experience with process characterization studies and specification justification studies (including knowledge of QbD principles and DOE studies) to investigate critical process parameters (CPPs) and to identify critical quality attributes (CQAs).
- Experience with impurity control strategies.
- 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.