Job Description  Director, Analytical Sciences

 

SUMMARY:

The individual will oversee analytical development and stability program management for the Analytical Sciences function in a manner which complies with corporate SOPs, GLPs and cGMPs.  He/she will be responsible for all analytical activities associated with conducting, coordination and management of stability studies for all Mirati development projects supporting pre-clinical lead candidate selection through clinical development, registration filings and up to commercialization. Additional responsibilities include coordinating cGMP vendor quality audits, maintaining all relevant files and reports required for regulatory submissions/health authority inspections/due diligence, and authoring of the CMC sections of regulatory health authority submissions.

 

RESPONSIBILITIES:

  • Lead technical execution of defined analytical strategies for product portfolio including CQA assessment, specification development, reference standard establishment and characterization
  • Drive and coordinate analytical method development, optimization, qualification, and validation activities across CMOs
  • Ensure timely completion of high-quality technical reports/protocols and integrated cross-functional reports and/or strategy documents. Primary author and/or reviewer for analytical sections of regulatory submissions and/or briefing documents to support clinical development
  • Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
  • Lead or participate cross-functional collaborations with process/formulation development or operations to define integrated product control strategies and support drug substance/drug product development/manufacturing
  • Oversee analytical testing including HPLC, dissolution, spectroscopy, compendia methods; demonstrate the ability to manage the analytical testing function
  • Represent department and present work at interdepartmental meetings
  • Identify, manage and coordinate outsourcing activities when appropriate
  • Serve as primary liaison with outside vendors on projects
  • Monitor and enforce GLP and GMP regulations

 

REQUIREMENTS:

  • Doctoral degree (Ph.D.) in Analytical Chemistry or related discipline plus 8 years of relevant industrial experience, or MS + 8 years, or BS +15 or more years’ experience
  • Knowledge of current Good Manufacturing Practices (cGMP)
  • Demonstrated knowledge of drug development, CMO management, manufacturing, supply chain management and regulatory CMC
  • Proven practical experience in scientific discipline with the ability to implement against strategic plans
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to evaluate analytical laboratory techniques (HPLC, LC/MS, USP test methods, etc.)
  • Significant analytical method development and method validation experience
  • Extensive experience with GLP and cGMPs, worldwide regulatory requirements and current industry practices
  • 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