Associate Director, CMC

Location
San Diego, California
Posted
May 01, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

SUMMARY:

Responsible for implementing CMC strategies and supporting the manufacture of drug substance and 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;  managing drug substance and drug product analytical method development, managing timelines for development and manufacturing activities performed at CMOs, tracking drug substance and drug product inventory levels, coordinating the distribution of clinical trial materials, coordinating cGMP vendor quality audits, 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:

  • May directly lead and manage CMO activities
  • Contribute to formulation and process development activities for all development programs
  • Provide manufacturing oversight for the production of drug substance and drug product at contracted manufacturing sites
  • Regulatory writing to support CMC submissions

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 drug development, CMO management, manufacturing, supply chain management and regulatory CMC
  • Proven ability to implement against strategic plans
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Demonstrated competencies in a core CMC discipline such as drug substance process development, drug product formulation development, drug substance manufacturing, and/or drug product production
  • Proven problem-solving skills are a must
  • Must possess the ability to effectively manage multiple projects
  • Ability to adapt rapidly and change focus based on real time results and findings
  • Exceptional written and verbal communication skills

EOE