Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
Desired Candidate Profile
This position reports into the Vice President of CMC & Supply Chain Logistics. The Director/Senior Director will lead efforts to develop and manufacture drug substance and drug product and to track clinical drug inventory.
- Serves as a supporting contact to direct production activities at CMOs and provide technical support and troubleshooting.
- Collaborates with other functions at Annexon to develop and implement specifications for drug substance and drug product specifications, and if needed, collaborates with QA and other functions to manage out of specifications, deviations and investigations.
- Participates with Clinical Operations to ensure that drug supplies are available on-time for support of clinical studies.
- Author of and/or reviews batch records, change controls, and other technical documents.
- Leads the development and validation of analytical methods according to ICH guidelines to ensure effective characterization and release of clinical batches.
- Designs and oversees formulation development and stability studies for drug substance and drug product for multiple compounds.
- Collaborates with QA, Regulatory Affairs and other functions towards timely generation of regulatory documents.
- Collaborates with discovery project leaders to determine if a viable initial development pathway for initial development exists for molecules being considered as development candidates.
- 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.
- 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.
- Small molecule experience is preferred.