Associate Director/Director, Drug Product Development

92121, San Diego
May 18, 2018
Required Education
Bachelors Degree
Position Type
Full time


Responsible for implementing CMC strategies and supporting the manufacture of drug product at CMOs to support GLP toxicology and Phase 1, 2 and 3 clinical studies.  Specific responsibilities may include but are not limited to the following;  drug product / formulation development, process optimization/validation, managing timelines and budgets for development and CMO manufacturing activities, coordinating the distribution of clinical trial materials, maintaining all relevant files and reports required for regulatory submissions/health authority inspections/due diligence, and assisting in the authoring of the CMC sections of regulatory health authority submissions.   


  • Plan and implement drug product formulation development and manufacturing activities according to cGMP requirements
  • Author, review and approve documents related to cGMP operations as appropriate, including drug product MBRs and EBRs
  • Oversee the shipment of drug product to the clinical and commercial packaging and labeling and distribution depots
  • Manage the implementation of drug product process improvements into CMOs and execute technology transfer
  • Support late stage formulation development activities including process validation batch planning and PAI preparation
  • Participate in preparation, review and approval of CMC sections of regulatory filings
  • As a member of CMC project teams, develop and execute project plans and schedules to support development team objectives
  • Identify and mitigate risks to CMC timelines and/or budgets relating to drug product manufacturing
  • Participate in periodic business and technical review meetings with drug product CMOs 


  • PhD or BS/MS with >12 years of experience chemistry, chemical engineering, biomedical engineering, pharmaceutical sciences or closely related discipline with relevant solid oral drug product development experience
  • Knowledge of current Good Manufacturing Practices (cGMP)
  • Demonstrated knowledge of small molecule drug product development and validation, CMO management and manufacturing
  • Established project management skills and proven ability to effectively organize and prioritize tasks to achieve strategic goals and manage multiple projects
  • Proven problem-solving skills are a must
  • Ability to adapt rapidly and change focus based on real-time results and findings
  • Exceptional written, verbal communication and interpersonal skills