Associate Director, CMC Analytical Development

Found in: beBee S US - 2 weeks ago

South San Francisco, United States Alumis Inc. Full time

Alumis 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 motivated Associate Director of Analytical Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will help to manage and drive analytical development and quality control activities from the preclinical phase through late-stage clinical development. Having analytical development expertise and experience in working with CMOs/CTLs, coupled with a thorough understanding of the associated quality and regulatory awareness are key assets.

 

Responsibilities


  • Manage and drive analytical development and quality control activities for Phase 1 to late-stage drug development
  • Manage development, validation, and transfer of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTLs
  • Establish and justify specifications for drug substances, starting materials, intermediates, and drug products
  • Oversee release testing and stability studies of drug substance and drug products at CMOs/CTLs, and trend stability and release data using statistical methods
  • Identify and characterize drug impurities and degradation products
  • Review and approve analytical results, protocols and reports
  • Participate, review and approve analytical investigations
  • Collaborate with CMC team, QA and CMOs/CTLs towards timely generation and approval of documents
  • Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams
  • Author technical reports and documents in support of regulatory filing
  • Prepare CMC documents for IND, IMPD, and NDA

     

    The Ideal Candidate


    • MS or PhD in chemistry or pharmaceutical sciences with minimum 8+ years of experience in analytical development
    • Strong leadership, organizational and communication skills
    • Comfortable in a fast-paced small company environment and is a strong team player
    • Experience in early to late-stage drug development
    • Experience in working with CMOs and CTLs
    • Experience with analytical techniques for small drug molecules and oral solid formulations required, including UPLC/HPLC, LC-MS, KF, dissolution testing, IR, particle size analysis, and solid-state characterization techniques
    • Extensive knowledge in ICH, cGMP and regulatory requirements
    • Proven track record in applying analytical techniques to solve challenging problems

       

      Alumis Values


      • Elevate
      • Challenge
      • Nurture


      This position is located in South San Francisco, CA. At this time, we are not considering fully remote applicants.


      The salary range for this position is $199,000 USD to $220,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.


      Alumis Inc. is an equal opportunity employer.

  • Associate Director, CMC Analytical Development

    Found in: beBee jobs US - 1 week ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis 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...

  • Associate Director, CMC Analytical Development

    7 days ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis 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...

  • Associate Director, CMC Analytical Development

    1 week ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis 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...

  • Scientist, CMC Analytical Development

    Found in: beBee jobs US - 2 weeks ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis 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 is seeking a highly motivated Contract...

  • Scientist, CMC Analytical Development

    Found in: beBee S US - 1 week ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis 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 is seeking a highly motivated...

  • Scientist, CMC Analytical Development

    7 days ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis 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...

  • Scientist, CMC Analytical Development

    2 weeks ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis 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...

  • Associate Director, Chemical Development

    3 days ago

    South San Francisco, United States Enigma Search Full time

    The Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the company’s pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...

  • Associate Director, Chemical Development

    1 week ago

    South San Francisco, United States Enigma Search Full time

    The Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the company’s pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...

  • Associate Director, Chemical Development

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    South San Francisco, United States Enigma Search Full time

    The Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the company’s pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...

  • Associate Director, Chemical Development

    Found in: Appcast US C2 - 1 week ago

    South San Francisco, United States Enigma Search Full time

    The Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the company’s pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...

  • Associate Director, Chemical Development

    7 days ago

    South San Francisco, United States Enigma Search Full time

    The Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...

  • Associate Director, Chemical Development

    4 days ago

    South San Francisco, United States Enigma Search Full time

    The Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...

  • Director CMC

    Found in: Jooble US O C2 - 2 weeks ago

    San Francisco, CA, United States EPM Scientific - Phaidon International Full time

    Director of CMC Location : San Francisco, CA Working situation : Hybrid Level : Director Our client, a blooming biotechnology company, is looking to expand their R&D capacity to support their growing pipeline including a new class of brain therapies. With a passion for treating neurodegenerative and neuropsychiatric disorders, they are at the...

  • Vice President of CMC Radiopharmaceutical Process Development

    Found in: beBee S US - 1 week ago

    South San Francisco, United States Abdera Therapeutics Inc Full time

    Vice President of CMC Radiopharmaceutical Process Developmentto lead the process development and GMP manufacturing of Abdera’s novel antibody guided radiopharmaceutical for clinical trials.The Vice Preside of CMC Radiopharmaceutical Process Development will provide oversights to cell line development, antibody process development and scale up, conjugation...

  • Vice President of CMC Radiopharmaceutical Process Development

    Found in: beBee jobs US - 2 weeks ago

    South San Francisco, California, United States Abdera Therapeutics Inc Full time

    Vice President of CMC Radiopharmaceutical Process Developmentto lead the process development and GMP manufacturing of Abdera's novel antibody guided radiopharmaceutical for clinical trials.The Vice Preside of CMC Radiopharmaceutical Process Development will provide oversights to cell line development, antibody process development and scale up, conjugation...

  • Senior Director, CMC Regulatory Affairs

    7 days ago

    South San Francisco, United States Allogene Therapeutics Full time

    Job Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...

  • Associate Director, CMC Regulatory Affairs

    Found in: Jooble US O C2 - 2 weeks ago

    San Mateo, CA, United States Mirum Pharmaceuticals Inc Full time

    MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into...

  • Associate Director, Formulation and Drug Delivery

    1 day ago

    South San Francisco, United States Astrix Inc Full time

    Our client is a clinical stage biopharmaceutical company dedicated to improving patients’ lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms. Title: Associate Director, Formulation and Drug Delivery Location: South San Francisco, California Salary: $175k - 215k Position Summary: We are seeking an experienced...

  • Associate Director, Formulation and Drug Delivery

    1 week ago

    South San Francisco, United States Astrix Inc Full time

    Our client is a clinical stage biopharmaceutical company dedicated to improving patients lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms. Title: Associate Director, Formulation and Drug Delivery Location: South San Francisco, California Salary: $175k - 215k Position Summary: We are seeking an experienced and...