Director/Senior Director, CMC

Work Location: South San Francisco, California (Hybrid)

Position Summary

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.

Responsibilities

• 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.

Key Qualifications

• 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.

What Annexon offers

• Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. We continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented candidates have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate. To learn more about Annexon’s diversity commitment, culture and values, please visit https://annexonbio.com/careers/
• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.

Compensation

Senior Director, CMC position is $238,500 - $265,000 per year. The starting salary for the Director, CMC position is $198,000 - $220,000 per year.  The starting salary for this position will be determined based on the candidate’s education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation. The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.  

Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.

EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging

Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.

Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees.  Inquiries must be sent to talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.