Associate Director CMC (Drug Substance)

San Diego, CA

  • Biosplice is seeking an organic chemist with extensive knowledge of small molecule process development and scale-up to join the CMC team.
  • The Associate Director CMC (Drug Substance) will be responsible for overseeing external API manufacture and developing reproducible, robust, and scalable synthetic routes.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Manage external API manufacture.
  • Provide technical guidance on synthetic routes and scale-up.
  • Transition molecules from discovery to development phase.
  • Perform chemistry experiments in the laboratory as needed to solve issues.
  • Critically analyze data.
  • Ensure API is made to all cGMP requirements.
  • Write technical documents, author IND & NDA module 3 DS sections.
  • Design salt forms, crystal habits and polymorphic characteristics to enhance stability and formulation properties.
  • Provide timing and budgets to meet program goals.
  • Develop chemistry to make DS tox. batches and subsequent phase 1-3 materials. 
  • Work cross-functionally to develop the optimum final product.


  • BS in organic chemistry with a minimum of 7 years’ experience or a PhD degree in organic chemistry, with 5-10 years of technical experience in the pharmaceutical or biotechnology industry.
  • Experienced in managing external API vendors globally.
  • Excellent knowledge of modern organic synthetic methods.
  • Demonstrated track record of innovation and problem solving in process chemistry.
  • Well versed in process development from the gram level to multi-kilo scale.
  • Previously developed robust, scalable, safe synthetic routes.
  • Project leadership experiences from early-stage to late-stage drug substance process development, preferably through registration batches and validation batches. Experiences in commercial manufacturing support is a plus.
  • Knowledge of physical form characterization and solid-state manufacturing techniques.
  • Experience in writing regulatory documents for example IND’s/NDA’s.
  • Experience in MBR’s, EBR’s, SOP’s review and authoring.
  • Excellent knowledge and understanding of analytical methodology and technology such as NMR, MS, HPLC, DSC, TGA, XRPD.
  • Excellent understanding of quality and regulatory requirements in the pharmaceutical industry pertaining to ICH, GMPs and global guidance’s and standards.
  • Excellent oral, written and presentation skills to share information accurately and clearly.
  • Ability to travel and work flexible hours as required.
  • Must be a punctual, reliable, team-player with a positive, can-do attitude and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.

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