Director/Associate Director, CMC

San Diego, CA

  • The Director/Associate Director, CMC will be responsible for small molecule drug substance and drug product contract manufacturing.
  • This position will lead tech transfers, process development and manufacturing operations to support the Phase 1,2 &3 studies through to commercialization.
  • The Director/Associate Director, CMC will serve as drug substance and drug product subject matter expert and author drug substance and drug product sections for regulatory documents.
  • The Director/Associate Director, CMC will also be responsible for dosage form development and pre-formulation characterization of small molecule drug candidates.
  • This individual will develop formulation strategies and timelines, provide technical leadership of formulation development and be responsible for internal laboratory investigations.
  • Ideally the position will also help define robust and scalable synthetic methodologies for drug substances.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Manage Samumed's drug substance and drug product Contract Manufacturing Organizations (CMOs), to ensure uninterrupted drug supply manufactured within GMP compliance
  • Manage manufacturing operations, including tech transfer, scheduling, logistics, batch record review, change controls, review of validation protocols and reports, development of specifications
  • Serve as drug substance and drug product subject matter expert on teams
  • Oversee late-stage development activities, including DOE and PAR studies, registration and validation manufacturing
  • Author CMC sections for regulatory documents, including IND amendments and NDAs
  • Oversight of CMOs for process development, scale up and GMP manufacturing activities
  • Authoring and review of written documents including development reports, technical memos, batch records, and relevant CMC sections for various regulatory filings, etc.
  • Developing dosage forms for clinical and commercial use
  • The position will be responsible for internal laboratory investigations and evaluation of new technologies
  • Interpreting complicated, multidimensional data and make recommendation on new processes and development directions
  • Guide drug substance manufacturing activities from early pre-clinical through to commercial
  • Assist in primary and secondary vendor CMO selections for drug substance and drug product
  • Work collaboratively with quality, regulatory, discovery and commercial to meet project goals 

Requirements

  • PhD in a physical science required
  • Minimum 10 years of progressive experience in a manufacturing within the pharmaceutical or biotechnology industry required
  • Skilled and knowledgeable in both synthetic organic chemistry and formulation science
  • Experience in launching and commercializing new products a plus
  • Deep knowledge of Good Manufacturing Practices (cGMP)
  • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
  • Experience with preparation and characterization of solid/liquid oral and topical formulations as well as sterile parenteral formulations and aseptic techniques.
  • Excellent understanding of quality and regulatory requirements in the pharmaceutical industry pertaining to ICH, GMPs and USP guidance and standards.
  • Excellent strategic thinking skills with demonstrated ability to successfully create and implement both short-term and long-term plans to support the department and business needs
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
  • Excellent knowledge and understanding of analytical instrumental technology and validation
  • Motivated self-starter and discipline to work independently with minimal guidance
  • 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@samumed.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.