Senior Director, CMC and Technical Operations - Gables Search Group : Job Details

Senior Director, CMC and Technical Operations

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Senior Director, CMC and Technical Operations

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Position is MOSTLY REMOTE, but must travel to Maryland occasionally.Senior Director, CMC and Technical OperationsMy client is expanding and seeks a Sr Director focused on manufacturing both API and small molecule drug products, analytical support, formulation development, and authorship of CMC sections of regulatory documents including INDs and NDAs.This Person Will Take On The Following Tasks

• Identify and partner with contract firms for API and drug product manufacturing, chemistry process development and scale-up, and analytical development.
• Troubleshoot and optimize manufacturing processes and analytical methods and direct the transfer of manufacturing processes and analytical methods to CDMOs.
• Direct and contribute to project teams to achieve project goals and coordinate work of team members.
• Ensure that manufacturing processes, analytical methods, and new formulations will meet FDA regulatory requirements, including GLP and GMP.
• Serve as the primary interface with Quality Assurance on matters related to CMC and methods development and validation.
• Author and review CMC sections of INDs, NDAs, PAS, Annual Reports and other FDA documents and submissions.

The ideal candidate will possess the following qualities and experience:

• BS/MS/PhD in chemistry and/or chemical engineering and 12+ years directly relevant industrial experience.
• 5+ years direct experience managing external CDMOs and participating in project teams composed of internal and external team members.
• Direct experience with and knowledge of the requirements for tech transfer of drug substance and drug product manufacturing processes and analytical method development and validation.
• Direct, hands-on experience with writing and reviewing CMC sections of INDs, NDAs and related regulatory documents.
• Direct experience in managing and directing formulation development, selecting and working with stage-appropriate CDMOs, and selecting and working with process improvement and scale-up labs.

Additional Preferred Expertise

• Thorough understanding of FDA requirements and guidelines for GMP manufacturing and analytical methods for clinical and commercial pharmaceuticals.
• Solid leadership skills with demonstrated knowledge and understanding of staff management practices and processes.

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionOther
• IndustriesHuman Resources Services

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