Work Location
Corporate Headquarters (South San Francisco, CA) Onsite – Hybrid
Position Summary
The Director/Senior Director – CMC Analytical incumbent is responsible for working closely with the SVP, CMC Research in leading and maintaining QA Manufacturing Operations. The Director/Senior Director – CMC Analytical will Lead preclinical to clinical analytical method development, qualification, and validation activities and oversee the testing and release of drug substance and drug product for Annexon’s programs through commercial development lifecycle activities while ensuring drug substance and drug product meet cGMP regulatory requirements and guidelines.
This role is also responsible for overseeing protein analytical characterization and stability studies conducted by internal and external labs.
Key Responsibilities
- Lead analytical method development and validation and stability across all projects
- Work closely with SVP, CMC Research to develop and execute analytical strategies for our early-phase and late-stage programs.
- Design and execute phase-appropriate analytical strategies including analytical method development, qualification and validation for drug substance and drug product (from preclinical through commercialization)
- Partner with members of the analytical team to finalize phase appropriate methods and formulations with an eye on commercial readiness.
- Develop and set specifications for raw materials, intermediates, drug substance, excipients and drug product
- Manage internal and external analytical method development and validation, developing product specifications and overseeing QC testing at the CMOs
- Review and author CMC analytical sections (Pre-IND, IND, BLA, & MAA submissions)
- Manage in-house CMC efforts and outsourced vendor activities relating to protein analytical characterization, product comparability, and stability studies
- Work closely with QA to collate, update, and perform trending analysis of stability data to support regulatory filings.
- Develop and maintain procedures in compliance with FDA, EMA, and local regulations and guidance, ICH guidelines, and industry best practices.
- Serve as the subject matter expert, identify key risks, develop mitigation plans, and ensure manufacturing timelines and deliverables are aligned with program and corporate goals.
Qualifications:
- M.S./Ph. D in Pharmaceutical Sciences, Chemical/Biochemical Engineering, or a related discipline with technical experience relevant to areas within the quantitative sciences disciplines
- Minimum of 10 – 15 years of experience in the pharmaceutical or biotechnology industry, with specific experience within areas of CMC development and with progression of programs through clinical development.
- Experience in managing analytical CMC development of drug substances and drug products from pre-clinical through registration and approval, with a focus on biologics is required (experience in small molecule analytical development is a bonus).
- Extensive experience (20+ years) in the pharmaceutical industry,
- An advanced degree in Chemistry or related field; a PhD is preferred.
- Thorough understanding of cGMPs, ISO, and ICH guidelines, and industry best practices
- Significant experience managing global CDMOs involved in clinical and commercial DS manufacturing.
- Strong knowledge of tools required for understanding product quality, formulation, analytical, release testing, and drug product development/manufacturing.
- Solid understanding of cGMP and global biologics regulatory landscape with experience authoring and reviewing CMC regulatory documents (IND, IMPD, CTA and BLA).
- In-depth understanding of drug development processes, and regulatory requirements for analytical method validation stages.
- Demonstrated ability to develop and execute strategic plans, drive innovation, and deliver results in a fast-paced, dynamic environment.
- Excellent communication and presentation skills, with the ability to effectively articulate complex scientific and clinical concepts to diverse audiences.
- Experience interacting with regulatory authorities and leading successful regulatory submissions and approvals.
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. To learn more about our diversity commitment, culture and values, 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..
Company Summary
Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon’s novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.
With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit annexonbio.com.
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.Staffing AgenciesAnnexon 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.
