Director, Process Development

2 months ago

South San Francisco, United States Alumis Inc. Full time

Alumis 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 Director of Process Development to help build our dynamic small molecule CMC group at Alumis. The successful candidate will be responsible for developing the manufacturing process of the drug substance and transferring the technology to our contract development and manufacturing organizations (CDMOs). The candidate will be able to direct and oversee contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs).


Responsibilities


  • Lead CDMO activities in drug substance development and manufacturing, including tech transfer, scale-up, process development, and optimization for early phase to late-phase drug development
  • Lead the design and execution of chemical development strategies and provide direction to the CROs and CDMOs during clinical development, registration batches, process validation, review, and evaluate release testing data
  • Serve as subject matter expert in drug substances and help drive best practices and technical advancements
  • Provide technical guidance and oversight (both internally and externally) to drive the phase-appropriate drug substance development
  • Apply principles of quality by design (QbD) to identify critical quality attributes (CQA) and to establish phase appropriate control strategies
  • Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plan, validation protocols/reports
  • Author the CMC sections of regulatory filings, including IND/IMPDs and NDA/MAAs
  • Document development activities as source reports for regulatory filings
  • Work effectively with the cross-functional CMC team to ensure timely delivery of drug substance throughout the full drug lifecycle
  • Implement best practices and drive continuous improvements in the drug-substance development process through technological innovation and problem-solving
  • Proactively identify risks and communicate effectively to functional teams across all levels of the organization.


    The Ideal Candidate


    • PhD./MS in Organic Chemistry, Chemical Engineering, or related field
    • Minimum of 12 years of industry experience with PhD is desired in small molecule drug substance development, including management of external vendors/CDMOs
    • Strong leadership with excellent collaboration and organizational skills
    • Expert knowledge in the design and execution of chemical development strategies
    • Capable of utilizing QbD principles to develop commercially viable manufacturing processes
    • Strong knowledge of cGMP, ICH, and regulatory requirements
    • Strong and independent problem-solving, ability to troubleshoot relevant to process chemistry issues is a must. Hands-on experience in working in the lab to solve process chemistry issue is highly desired.
    • Highly proficient oral and written communication abilities
    • Comfortable in a fast-paced small company environment
    • Ability to travel domestically and internationally to Alumis external CROs and CDMOs


      Education 


      • PhD./MS in Organic Chemistry


        Alumis Values


        • Elevate  
          • Challenge  
            • Nurture  

                 

              This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.   

                 

              The salary range for this position is $220,000 USD to $235,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.   

               

              Alumis Inc. is an equal opportunity employer. 


  • Director, Process Development

    6 days ago

    South San Francisco, United States BioSpace, Inc. Full time

    Job Details Alumis 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...

  • Director, Process Development

    6 days ago

    South San Francisco, United States Alumis Inc Full time

    Alumis 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...

  • Director, Process Development

    2 months ago

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

    Alumis 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...

  • Director, Process Development

    2 months ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: Alumis 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...

  • Associate Director, Radiopharmaceutical Process Development

    4 weeks ago

    South San Francisco, United States Abdera Therapeutics Full time

    Job DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...

  • Associate Director, Radiopharmaceutical Process Development

    4 weeks ago

    South San Francisco, United States Abdera Therapeutics Full time

    Job DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...

  • Assoc. Dir, Purification Process Development

    4 weeks ago

    South San Francisco, United States Vaxart, Inc. Full time

    The Associate Director, Purification Process Development is responsible for understanding, designing, executing, and reporting purification processes with a focus on development and manufacture of Ad5 vectors used for oral vaccines.  Must be very familiar with Clarification, Chromatographic, and NFDF type unit operations. Evaluate existing downstream...

  • Assoc Dir Purification Process Development

    4 weeks ago

    South San Francisco, United States Vaxart Full time

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration. Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is...

  • Assoc Dir Purification Process Development

    6 days ago

    South San Francisco, United States Vaxart Inc. Full time

    Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration. Vaxart has demonstrated that its proprietary tablet vaccine delivery platform is...

  • Director of Process and Manufacturing Science

    3 days ago

    South San Francisco, United States Kelly Services Full time

    Director of Process and Manufacturing Science Kelly® Science & Clinical is seeking a Director of CMC MSAT for a direct-hire position at a cutting-edge cell therapy manufacturing client in South San Francisco, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The...

  • Director of Development

    2 weeks ago

    San Francisco, United States Conard House Full time

    POSITION OVERVIEWConard House is seeking a Director of Development to lead and revamp our fundraising efforts. The Director of Development is responsible for planning and implementing a comprehensive fundraising program that includes major gifts, corporate and foundation giving, planned giving, and special events. The Director of Development works closely...

  • Director of Development

    3 weeks ago

    San Francisco, United States Conard House Full time

    POSITION OVERVIEWConard House is seeking a Director of Development to lead and revamp our fundraising efforts. The Director of Development is responsible for planning and implementing a comprehensive fundraising program that includes major gifts, corporate and foundation giving, planned giving, and special events. The Director of Development works closely...

  • Process Development Engineer

    4 weeks ago

    San Francisco, United States PetsApp Full time

    Process Development Engineer San Francisco, CA - In-person, full time POSITION OVERVIEW: We are looking for a process engineer that self identifies as a “builder” that is ready to turn chemical engineering designs into prototypes, and protypes into a pilot. You will play a vital role in development and scale-up of our core technology platform, producing...

  • Senior Scientist, Process Development

    2 months ago

    South San Francisco, California, United States Cellares Full time

    Position SummaryCellares is seeking an innovative and highly motivated Senior Scientist with expertise in cell therapy manufacturing to join the Process Development team. This individual will interface across many parts of the company and contribute significantly to the development of our advanced cell therapy manufacturing platform. The primary focus of...

  • Director, Market Development

    4 weeks ago

    South San Francisco, United States Cytovale, Inc Full time

    Job DescriptionJob DescriptionSalary: $180K - $200KAbout the CompanyCytovale is a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases.  Cytovale’s IntelliSep test is the first and only stand-alone sepsis detection assay to quickly and accurately analyze white blood cell...

  • Director, Market Development

    1 week ago

    South San Francisco, United States Cytovale, Inc Full time

    Job DescriptionJob DescriptionSalary: $180K - $200KAbout the CompanyCytovale is a medical diagnostics company focused on providing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases.  Cytovale’s IntelliSep test is the first and only stand-alone sepsis detection assay to quickly and accurately analyze white blood cell...

  • Senior Process Development Associate, Upstream

    3 days ago

    South San Francisco, California, United States Encoded Therapeutics Full time

    About Encoded TherapeuticsEncoded Therapeutics is a pioneering biotechnology company dedicated to advancing precision medicines for a wide range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery, focusing on delivering life-changing advances for individuals with genetic disorders not...

  • Director, Pharmaceutical Development

    4 weeks ago

    San Francisco, California, United States Nurix Therapeutics Full time

    CompanyNurix 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,...

  • Project Manager

    22 hours ago

    San Francisco, California, United States Chinatown Community Development Center Full time

    About the RoleThe Project Manager will be responsible for overseeing the development of affordable housing and mixed-use projects, from initiation to completion. This includes coordinating with various stakeholders, managing budgets and schedules, and ensuring compliance with regulations.About the OrganizationChinatown Community Development Center is a...

  • Engineering Manager, Developer Experience

    23 hours ago

    San Francisco, California, United States Stellar Development Foundation Full time

    About the RoleWe are seeking an experienced Engineering Manager to lead our Developer Toolchain team at the Stellar Development Foundation. As a key member of our team, you will be responsible for managing the development of our open-source Developer Toolchain for our cutting-edge Smart Contracts platform.Key ResponsibilitiesDefine Feature Strategy: Help...