VP, CMC

Job Description:

We currently seek a Vice President of CMC to lead all process development and manufacturing efforts critical for the advancement of clinical drug candidates. The incumbent will be a member of the senior leadership team and contribute to the development of the CMC strategy for all manufacturing ranging from pre-clinical, Phase I, Phase II/ Phase III through commercial launch.

Key Responsibilities:

  • Provide strategic oversight and leadership on all biologic development activities
  • Oversee CMO-based manufacturing of monoclonal antibodies and antibody-drug in early and late stage development and commercialization.
  • Manage project and logistics of outsourced development and manufacturing activities at CMOs.
  • Use sound scientific and engineering criteria to evaluate manufacturing processes, identify and execute process improvement/optimization strategies, and ensure successful manufacturing of biologic products.
  • Identify appropriate CMOs, complete contract(s), and manage technology transfer to support scale-up and GMP manufacturing.
  • Support regulatory interactions and contribute to content of regulatory documents (IND, briefing packages, BLAs, MAAs) as needed.
  • Facilitate the preparation process for internal and external audits.
  • Direct all aspects of the manufacturing and supply of clinical trials material through PPQ. In collaboration with commercial supply operations, support the seamless transfer of supply responsibilities from clinical trial development to commercial supply.
  • Establish and oversee process development strategy and translate into deliverable and milestones to ensure phase-appropriate manufacturing processes; provide informal and formal updates to executive leadership.
  • Establish strong and effective communication/collaboration with development partners for small molecule products/intermediates.
  • Form and lead a high-performing team with product expertise and focus including Technical Operations and Process Sciences disciplines.
  • Manage, coach, and develop direct reports and be an active participant in the interview and selection process for future hires.
  • Ensures timely delivery of quality drug product to support clinical and commercial development in alignment with corporate goals and objectives.

Requirements:

  • Ph.D. in biochemical engineering, pharmaceutical chemistry, biochemistry, or appropriate technical discipline with 15-20 years of industrial bioprocess development and manufacturing experience, including mammalian cell culture and associated downstream unit operations.
  • Experience in working with monoclonal antibodies with demonstrated expertise in upstream and downstream process development and analytical expertise is a bonus.
  • Experience in late stage manufacturing and process validation with monoclonal antibodies.
  • Experience in management of outsourced manufacturing/development activities at CMOs.
  • Ability to influence others without direct authority.
  • Ability to communicate and connect with all levels of the organization
  • Strong project leadership and resource management skills.
  • Require excellent written/oral communication skills

Additional Information:

  • Please include a cover letter that highlights your qualifications that matches our requirements and send resumes to resumes@annexonbio.com.