Job Description  Senior Director/Director, Analytical Development

 SUMMARY:

The individual will oversee and direct all analytical development and control regulatory and manufacturing strategies for new and mature products.  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 and including commercialization.  He/she will provide guidance and support to internal groups such as business development, marketing, regulatory, quality and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and GMP).   He/she will provide strategic input and risk assessments and oversee preparation of CMC regulatory submissions and interact with regulatory agencies.  He/she will select, develop and evaluate personnel to ensure the efficient operation of the function.

RESPONSIBILITIES:

  • Develop and recommend analytical regulatory and manufacturing strategies
  • Lead technical execution of defined analytical strategies for product portfolio including CQA assessment, specification development, reference standard establishment and product characterization
  • Direct analytical method development, optimization, qualification, and validation activities for raw materials, intermediates, drug substance, drug product intermediates, and finished drug products internally and across CMOs
  • Oversee stability study design, execution, monitoring, reporting, and data trending and analysis
  • Responsible for development and implementation of analytical function and organization
  • 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
  • Provides leadership for deviation events or failure investigations at contractor sites. Leads implementation of corrective actions and quality system improvements.
  • 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 R&D/product development and supply chain operations to define integrated product control strategies and support drug substance/drug product development/manufacturing
  • Oversee analytical testing for development, clinical and commercial materials
  • 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
  • Assist and advise the Technical Operations Leadership as required. Provides recommendations and input on departmental policies, new product opportunities, product developmental strategies, procedures, resourcing, budgets, goals and objectives.

 REQUIREMENTS:

  • Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 15 years of relevant industrial experience, or BS +18 or more years’ experience
  • Extensive management experience (12+ years) with GLP and cGMPs, worldwide regulatory requirements and current industry practices
  • Demonstrated knowledge of drug development, CMO management, manufacturing, supply chain management and regulatory CMC for development and commercial stage programs
  • Extensive experience preparing and maintaining regulatory filings (IND, NDA,MAA)
  • Successful history building and managing analytical functions
  • Exceptional written and verbal communication skills
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
  • Significant analytical method development and method validation experience
  • Ability to evaluate analytical laboratory techniques (HPLC, LC/MS, USP test methods, etc.)
  • Proven problem-solving skills are a must
  • Ability to travel up to 25% domestically and internationally

EOE