Experienced Manager, Analytical Chemistry (API, Drug Substance) – NC Pharma/Will Relo

Job Type: 
Regulatory Affairs and Medical Affairs
Data Management, Biostatistics and Programming
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, a high profile specialty pharmaceutical firm in Research Triangle Park, NC, is actively recruiting for a skilled and knowledgeable Analytical Chemist to assume critical role on its management team.  This role will focus on the development of APIs/Drug Substance.  Right candidate will combine exceptional scientific credentials with a developmental supervisory style, broad regulatory knowledge and keen operational savvy

Company will pay industry-leading wage, including relo, to attract and retain a star.

This company is experiencing unprecedented growth. It boasts unique technology which is the foundation for its growing portfolio.  This Manager will oversee a small team of Analytical Chemists as well as the work performed by CMOs.  Travel is estimated at 15-20%.

Key Things to Note:

  • Role will focus on Active Pharmaceutical Ingredients (APIs) and Drug Substance.  Seek Analytical Chemist with substantial experience with both.
  • Company relies heavily on CMOs.  Right candidate will be accustomed to overseeing the work performed by 3rd party vendors.
  • This is an emerging business in which policy, practices and procedures are still being refined.  Seek candidate with the ability to develop and enhance analytical methods, streamline development activities, and help build SOPs.
  • This Manager will be responsible for simultaneously leading numerous projects.  Exceptional scientific credentials must be complemented by superb project management and supervisory skills.
  • Role will involve extensive Regulatory and SOP Writing.  Seek scientist with strong writing/editing skills.

This Manager will be responsible for 1) overseeing outsourced analytical development activities associated with the development, validation and technology transfer of chemical reagents, starting materials, intermediates and APIs as well as the 2) in-house analytical team that supports new synthetic route and process chemistry initiatives.  Specific duties will include:

  • Oversees the development and validation of analytical methods for small molecules for starting materials, intermediates, and active pharmaceutical ingredients:
    • Develops and/or assesses the suitability of the analytical methods for intended purpose: ensuring an appropriate characterization and control strategy is set to maintain a manufacturing process.
    • Authors or approves analytical methods
    • Authors or approves method validation protocols and reports
    • Authors and/or reviews analytical specifications
  • Oversees testing at CMO’s
    • Reviews testing sections of process development protocols and reports
    • Defines testing requirements
    • Responsible for technical review of analytical data and laboratory documents
    • Observes, as needed, testing at the CMO’s to assess technical abilities
  • Monitors CMO’s performance and manages the relationship to ensure maximum quality and performance
  • Leads technical analytical support of API for approved commercial products, including:
    • Investigations of deviations / technical troubleshooting
    • API analytical method life cycle management and post marketing commitment effort
  • Authors technical content of CMC sections of Regulatory filings (domestic and international)
    • Address comments from Regulatory Agencies regarding analytical methods
    • Provide subject matter expertise and support for Regulatory interactions – inspections / audits
  • Provides input to the development of manufacturing plans, budgets and timelines.

Targeted candidate will offer a Chemistry Degree (advanced degree expected) and 7+ years of directly related analytical chemistry experience, with a focus on API analytical development.  Other priorities include:

  • Extensive knowledge of the analytical method development and validation as well as specifications to appropriately control the manufacture of active pharmaceutical ingredients
  • Substantial supervisory experience
  • Expertise in cGMP/cGLP guidelines and requirements
  • Demonstrated ability to lead projects conducted at third party manufacturers and laboratories
  • Experience in authoring technical reports and CMC sections for regulatory filings
  • Ability to manage multiple projects, set priorities, and work in a fast-pace environment
  • Hands-on use of HPLC and GC equipment
  • Longevity, impact and growth in previous roles

Finally, and critically we seek a candidate who will thrive in a highly dynamic setting.  Someone who can switch gears readily, stay focused despite disruption and who can bring enhancements and ideas.  The future is very bright, but the present is ever-changing.  Seek a contributor who enjoys the challenge and stays focused on the mission.

Please forward Word resume for prompt consideration.