Director Biologics API Chemical Development CMC

2 weeks ago

San Diego, United States Clinical Dynamix, Inc. Full time
About the Role:

Seeking a highly motivated and talented biologics leader within CMC (antibodies, gene therapy) in the areas of upstream and downstream API development, optimization and manufacture. The successful candidate will work on research and development of biologics processes and regulatory document contribution internally and will also perform and direct tech transfer and batch manufacturing from FIH through commercial phases with external partners. This leader provides direction and support for CMC API biologics programs, develops technical teams, and may lead work streams and projects within Chemical Development. Expertise regarding biologics process development for both upstream and downstream areas will enable significant impact upon company projects.

Your Contributions (include, but not limited to):

  • Oversee the chemical development activities for biologics, including API development, vendor tech transfer, manufacturing and support, process validation, and troubleshooting
  • Lead and manage the API biologics team within CMC in collaboration with directors and teams in CMC drug product and analytical groups, ensuring the successful execution of development programs for biologic products
  • Collaborate closely with cross-functional teams, including Research and Development, Quality Assurance, Regulatory Affairs, and Clinical Development to ensure timely and successful CMC activities
  • Develop and implement CMC strategies for biologics API
  • Provide technical expertise and guidance on CMC-related issues, ensuring compliance with regulatory guidelines and requirements
  • Actively participate in regulatory submissions, including INDs, NDAs, and BLAs, and represent the company in interactions with regulatory authorities

Requirements:

  • BS/BA degree in Chemistry and 10+ years of experience in pharmaceutical biologics, including API development and manufacturing experience, OR
  • MS/MA degree in Chemistry and 8+ years of similar experience above, OR
  • PhD in Chemistry and 5+ years relevant industry experience
  • Proven track record of successfully leading CMC teams and managing complex projects
  • Expertise in both upstream and downstream processing and development is highly desirable
  • Deep understanding of regulatory guidelines and requirements related to CMC activities
  • Strong leadership and communication skills, with the ability to collaborate effectively across teams and stakeholders
  • Experience managing external partners, CDMOs and manufacturers
  • Excellent problem-solving abilities and a proactive approach to decision-making
  • Proficient in all aspects of modern biologics development, purification, and analysis
  • Sees broader picture, impact on multiple programs, teams and/or departments
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

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