Job Description  Associate Director/Director, Drug Product Development

SUMMARY:

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.

RESPONSIBILITIES:

  • 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

REQUIREMENTS:

  • 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

EOE