Director/Senior Director, CMC Analytical
2 months ago
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
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
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
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 Agencies
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 with the Subject Heading: Staffing Agency Request.
-
Associate Director, CMC Analytical Development
2 months ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The small molecule CMC team is seeking a highly...
-
Senior Scientist II, CMC Analytical Development
2 months ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.The Alumis team seeks a highly motivated Sr. Scientist...
-
San Francisco, California, United States Nurix Therapeutics Full timeCompanyNurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries,...
-
San Francisco, California, United States Nurix Therapeutics Full timeCompanyNurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries,...
-
Senior CMC Quality Control Manager
3 days ago
San Francisco, California, United States SciPro Full timePosition Overview:SciPro is looking for a dedicated and skilled individual to fill the role of Senior Manager in the CMC Quality Control division. This position is crucial for the advancement of innovative treatments aimed at rare and ultra-rare diseases.Key Responsibilities:The Senior Manager will oversee the comprehensive review of Quality Control (QC)...
-
Senior CMC Quality Control Manager
3 days ago
San Francisco, California, United States SciPro Full timeWe are looking for a dedicated and skilled individual to fill the role of Senior Manager in the CMC Quality Control division, driven by a commitment to advancing innovative therapies for rare and ultra-rare conditions.The Senior Manager will oversee all facets of Quality Control data evaluation for both commercial and clinical initiatives, encompassing...
-
South San Francisco, California, United States pliant-therapeutic Full timePliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the...
-
Director / Senior Director, Medicinal Chemistry
2 months ago
South San Francisco, California, United States IDEAYA Biosciences Full timeIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics.We are applying these capabilities across multiple classes of precision medicine, including direct targeting...
-
South San Francisco, California, United States Annexon, Inc. Full timeWork LocationCorporate Headquarters (South San Francisco, CA) – HybridPosition SummaryThis role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet...
-
South San Francisco, California, United States Surf Search Full timeDirector/Senior Director, Regulatory Medical Writing (Remote).Position Overview: The position, reporting to the Sr. Director, Head of Global Regulatory Portfolio Management, with a dotted line reporting to the Interim Head of Medical Writing, will be the medical writing lead for clinical regulatory documents. A successful medical writer will be able to write...
-
Associate Director, Statistics
4 weeks ago
South San Francisco, California, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
Director, Process Development
1 month ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an experienced highly motivated...
-
Senior Director of Marketing
1 month ago
San Francisco, California, United States AppsFlyer Full timeAt AppsFlyer, we stand as the market leader in mobile attribution and marketing analytics, enabling top-tier brands to sharpen and elevate their marketing strategies. We are seeking a strategic and seasoned Senior Director of Marketing to guide our North American programs with expertise, driving continued expansion and solidifying our position at the...
-
Associate Director/Director
2 months ago
South San Francisco, California, United States Annexon, Inc. Full timeWork LocationCorporate Headquarters (South San Francisco, CA) Position SummaryThis position reports into the Vice President / Executive Director of Global Clinical Operations. The Associate Director/Director - Clinical Operations (Ophthalmology) will contribute to the development and implementation of clinical studies. Responsibilities include providing...
-
Senior Director's Assistant
2 months ago
San Francisco, California, United States Pacific Gas and Electric Company Full timeRequisition ID # Job Category: Administrative / Clerical Job Level: Individual ContributorBusiness Unit: Operations - OtherWork Type: HybridJob Location: Auburn; Alameda; Alta; American Canyon; Angels Camp; Antioch; Auberry; Avenal; Avila Beach; Bakersfield; Balch Camp; Bear Valley; Belden; Bellota; Belmont; Benicia; Berkeley; Brentwood; Brisbane; Buellton;...
-
Director, Regulatory Strategy
3 weeks ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motivated...
-
Director, Pharmaceutical Development
3 weeks ago
San Francisco, California, United States Nurix Therapeutics Full timeCompanyNurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries,...
-
South San Francisco, California, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our...
-
Senior Director of Clinical Quality Assurance
1 month ago
South San Francisco, California, United States Alumis Inc. Full timeAlumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance...
-
Senior Director, Product
2 weeks ago
San Francisco, California, United States Xero Full timeXero is a beautiful, easy-to-use platform that helps small businesses and their accounting and bookkeeping advisors grow and thrive. At Xero, our purpose is to make life better for people in small business, their advisors, and communities around the world. This purpose sits at the centre of everything we do. We support our people to do the best work of their...