Senior Formulation Scientist, CMC

San Diego, CA

  • Samumed is seeking a motivated and talented scientist to join the Formulation Development Group in the CMC department.
  • The Formulation Scientist will 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 GMP manufacturing at contract manufacturing organizations (CMOs), and update multidisciplinary team with technical, timeline and budget issues.
  • The position will be responsible for internal laboratory investigations and evaluation of new technologies that could advance Samumed programs.
  • This is a full-time position in Samumed’s San Diego headquarters. 

Specific Responsibilities

  • 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.
  • Mentoring and supervising junior technical staff
  • Serving as formulation lead in multidisciplinary project teams and/or sub-teams.
  • Developing dosage forms for clinical and commercial use
  • Developing stable and bioavailable formulations for different stages of development (e.g. solution/suspension-based formulations, parenterals, etc.)
  • Generate data for project progression and regulatory filings, conduct optimization and process scale up studies
  • Interpreting complicated, multidimensional data and make recommendation on new processes and development directions
  • Transfer of technical knowledge to contract research sites (CRO) for onsite clinical preparations
  • Oversight of outsourcing activities such as scale-up and technology transfer to contract manufacturing sites (CMO) partners for clinical trial manufacture externally as well as support clinical trial material manufacture within Samumed

Requirements

  • Ph.D in Chemistry, Pharmaceutical Sciences or related Physical Science and 6+ years of experience working in formulation development in the pharmaceutical or biotechnology industry or MS/BS with 10+ years of relevant formulation experience.
  • Direct experience working with CMOs.
  • Experience with enabling formulation development and scale up production is highly desired
  • Experience working with small molecule new chemical entities (NCEs) and exposure to early phase formulation development activities.
  • Experience with a range of dosage forms, including liquids, solids and oral.
  • Proven experience managing the scale-up and manufacturing of pharmaceutical dosage forms.
  • Experience with phase 3 & commercial manufacturing preferred.
  • Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines.
  • Excellent leadership, teamwork and organizational skills.
  • Solid verbal and written communication skills.
  • GLP, GMP, GxP experience.
  • Motivated self-starter.
  • Positive, adaptable, can-do attitude.
  • Ability to travel and work flexible hours as required.

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.