This position reports into the Vice President of CMC & Supply Chain Logistics. The Associate Director or Director will oversee efforts to develop and manufacture drug substance and drug product and to track clinical drug inventory.
· Act as a supporting contact to oversee production activities at CMOs and provide technical support and troubleshooting.
· Collaborate with other functions at Annexon to develop and implement specifications for drug substance and drug product specifications and if needed, collaborate with QA and other functions to manage out of specifications, deviations and investigations.
· Collaborate with Clinical Operations to ensure that drug supplies are available on-time for support of clinical studies.
· Author and/or review batch records, change controls, and other technical documents.
· Oversee the development and validation of analytical methods according to ICH guidelines to ensure effective characterization and release of clinical batches.
· Design and oversee formulation development and stability studies for drug substance and drug product for multiple compounds.
· Collaborate with QA, Regulatory Affairs and other functions towards timely generation of regulatory documents.
· Work with discovery project leaders to determine if a viable initial development pathway for initial development exists for molecules being considered as development candidates.
Qualifications and Other Required Knowledge and Skills:
· A BS/MS/PhD in Analytical Chemistry, Biochemistry, or Pharmaceutical Chemistry is required, with 10+ years of related industry experience in drug substance and/or drug product development, production and analysis.
· An in-depth knowledge and drug development experience in biologics, preferably monoclonal antibodies,is strongly desired, from early to BLA stage development.
· Familiarity with protein purification, protein analytical and characterization techniques.
· Familiarity and working knowledge of GMP/ICH regulations required, with experience working in a GMP facility preferred.
· Team oriented professional with excellent organizational, communication, leadership and problem-solving abilities.
· Working knowledge of quality by design and risk management is strongly desired. Knowledge of ICH Q8/Q9 and Q10 is preferred.
· Experience overseeing external CRO based resources for production of drug substance and drug product.
· Demonstrated ability to successfully coordinate multiple work streams and development efforts in a timely and economically responsible manner in small, start-up biotech companies.
· Experience and familiarity with successful operation in the biologics CMC regulatory environment for early to mid-stage development.