CMC Director

About the RoleThis senior leadership position requires an experienced professional with a strong background in small molecules and solid oral dose formulations. As the CMC Regulatory Lead Director, you will oversee all CMC regulatory strategies and collaborate closely with cross-functional colleagues, including regulatory operations, quality, CMC,...

Job DescriptionThe Associate Director, CMC Regulatory Affairs role is a highly sought-after position at ORIC Pharmaceuticals, where you will lead CMC regulatory activities within the Regulatory Affairs department. Your primary objective will be to support all clinical development programs of oncology products.

Job DescriptionWe are seeking a highly motivated and creative CMC drug substance professional to join our CMC team in San Diego. The successful candidate will report to the senior director and head of CMC, working closely with internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical...

Key ResponsibilitiesResponsible for the technical leadership and CMC operational management and process development for drug substance and drug products from pre-clinical through commercial.Identify and evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, assist in negotiating effective supply/technical...

About Kumquat Biosciences Inc.Kumquat Biosciences is dedicated to revolutionizing cancer treatments through innovative drug discovery and development. Our accomplished management team and distinguished scientific founders collaborate to translate cutting-edge research into novel therapeutics. With a proven track record of drug discovery and development, our...

About the JobThis is a hybrid role that offers the opportunity to work with a cutting-edge technology platform optimized for targeted radiation therapies. As an Associate Director, you will be responsible for managing the radiolabeling processes development team and supervising the daily operations of the extended on-site CMC team.You will also be...

Are you a seasoned professional seeking a challenging role in the biotech industry? We are currently looking for a Senior CMC Leader to join our team at EPM Scientific, a top 10 pharmaceutical company. This position offers an exceptional opportunity to lead cross-functional teams and contribute to the development of cutting-edge therapies.About the RoleWe...

Company OverviewVir Biotechnology, Inc. is a clinical-stage biopharmaceutical company dedicated to harnessing the power of the immune system to combat serious infectious diseases and cancer. Our mission is to discover and develop innovative medicines that transform lives.We believe that our success is driven by the passion and dedication of our colleagues....

At Arthrosi Therapeutics Inc, we are seeking a seasoned professional to lead our drug product development efforts. The Director of Pharmaceutical Development will oversee all aspects of drug product development, ensuring seamless progression from clinical phase 3 trials to product registration and commercialization.Key Responsibilities:Lead and manage the...

The ideal candidate will have a strong background in clinical pharmacology, with experience in developing and executing clinical pharmacology strategies. They will have expertise in pharmacokinetics, pharmacodynamics, and pharmacometrics, with a deep understanding of regulatory requirements.The successful candidate will be responsible for leading...

ResponsibilitiesThe Executive Director of Pharmaceutical Operations will be responsible for leading the CMC team in the development and manufacture of pharmaceutical products. This role requires a strong technical background, with expertise in formulation development, process optimization, and technology transfer. The ideal candidate will have a proven track...

Job Summary:We are seeking a seasoned Regulatory Affairs Director to lead our cell therapy regulatory strategy and activities. This pivotal role will spearhead regulatory planning, agency interactions, and submissions.About Us:Ignite Human Capital is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and...

Job OverviewThe Director of Small Molecule Drug Development will lead and oversee all aspects of drug product development, ensuring seamless progression from clinical phase 3 trials to product registration, NDA filing, and commercialization. This role requires a strong background in oral small molecule drug development, with expertise in CMC regulatory...

Job OverviewCentivax is seeking an experienced mRNA Bioprocessing Director to lead our process development and GMP efforts for novel mRNA vaccines and therapeutics. In this role, you will be responsible for leading quality and process-related activities to ensure the successful launch of mRNA projects. You will represent Centivax as Lead on mRNA CMC Project...

About Us:Septerna is a biotechnology company based in South San Francisco, CA, dedicated to developing novel therapeutics for patients with high unmet needs. Our Native Complex Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables access to modern structural and screening...

Director, Drug Product Manufacturing SMEFully remote opportunity available.Job Reference #24-06AMapp Biopharmaceutical, Inc. is a pioneering biotech company specializing in the development of life-saving monoclonal antibody treatments for various infectious diseases and biodefense programs. Headquartered in San Diego, our innovative approach focuses on...

Job OverviewThis position plays a critical role in driving business development activities within WuXi's CMC small molecule development and manufacturing division. The Senior Director Strategic Accounts will work closely with STA's other BD team members and senior management team in China to develop and execute effective strategies for increasing small...

Career Opportunities at Arthrosi Therapeutics IncWe are driven by our mission to improve patient outcomes with innovative therapies. As a key leader, you will have the opportunity to shape the future of our breakthrough therapy and contribute to its successful global launch.The ED/VP of CMC will lead and manage the drug product development for phase 3...

Job DescriptionWe are seeking a Principal Scientist/Associate Director Antibody Process Development to lead our Adcentrx CMC team. The successful candidate will be responsible for developing novel targeted biotherapeutics that can make a difference in the life of cancer patients. This position will focus on antibody manufacture, including upstream and...

Our CultureWe value diversity, inclusivity, and teamwork at Crinetics. Our workplace culture is dog-friendly and supportive, promoting work-life balance and employee satisfaction. We strive to make a real difference in the lives of patients through rigorous innovation and operational excellence.