Executive/Senior Director, Chemical Development

Location
92121, San Diego
Posted
Jun 13, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

SUMMARY:

The individual will oversee and direct all chemical process research and development and provide technical oversight of the supply of small molecule drug substance (API) for all Mirati development projects supporting pre-clinical lead candidate selection through clinical development, registration filings and up to and including commercialization.  All process research and development as well as GMP manufacturing activities are executed in partnership with contract research or development and manufacturing organizations (CRO/CDMO).  He/she will provide guidance and support to internal groups such as business development, marketing, pharmaceutical and analytical development, regulatory, quality, manufacturing and supply chain 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.  Ideal candidates will have significant experience with process R&D and GMP manufacturing combined with exceptional project leadership, organizational, and communication skills.  He/she will select, develop and evaluate personnel to ensure the efficient operation of the function.

RESPONSIBILITIES:

  • Develop and recommend chemical development and manufacturing strategies
  • Lead technical execution of defined strategies for process research and route development, process development and scale-up, definition of process controls and technology transfer
  • Direct chemical development, optimization, qualification, and validation API manufacturing
  • Responsible for development and implementation of chemical development function and organization
  • Works closely with leadership team on key aspects and strategy for Mirati Intellectual Property
  • Identify suppliers for starting materials and intermediates, and develop plans for consistent and continuous supply
  • 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
  • Supply drug substance and/or metabolites of drug substance with stable or radiolabels as needed for analytical development, non-clinical studies, and clinical protocols
  • Represent chemical development at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
  • 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 analytical/product development and supply chain operations to define integrated product control strategies and support drug substance/drug product development/manufacturing
  • 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
  • Provides recommendations and input on departmental policies, new product opportunities, product developmental strategies, procedures, resourcing, budgets, goals and objectives. Assist and advise the Technical Operations Leadership as required


REQUIREMENTS:

  • Doctoral (Ph.D.) or Masters (M.S.) degree in Chemistry, Chemical Engineering or related discipline plus 13 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
  • Late stage API experience with DoE, QbD, FMEAs and process validation to enable filing of an NDA
  • Extensive experience preparing and maintaining regulatory filings (IND, NDA, MAA)
  • Organized and able to build and lead a functional group of high-level individual contributors, and cross-functional teams, utilizing solid interpersonal and team skills
  • Successful history building and managing chemical development 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
  • Proven problem-solving skills are a must
  • Ability to travel up to 30% domestically and internationally

EOE