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.

Requirements

  • 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.

Please submit your resume or additional inquiries to apply@biosplice.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.