Well funded high-tech Biotech with over $400M in funding from the likes of Pfizer, Amgen, Bayer, Pfizer and Sanofi developing a novel LNP mRNA Gene Editing platform. Seeking experienced CMC Leaders to support the growth of the company.
As VP of CMC, you will provide strategic direction, technical leadership and operational execution for successful CMC development activities. Partner with CMC, Pre-clinical and Clinical functions, and global CMO partners to provide technical leadership, direction, and timely execution.
- Oversee all CMC aspects of development including process chemistry, GMP manufacture and clinical supply, and formulation development.
- Manage multiple priorities in a fast-paced environment, ensuring uninterrupted drug supply for IND-enabling activities and clinical trials.
- Identify, evaluate and select CMOs for process optimization, formulation work, GMP manufacture, and supply.
- Formulate drug development strategies to meet clinical and commercial needs, ensure product quality and regulatory compliance, and optimize the supply chain.
- Coordinate with Quality Assurance to implement GMP processes, review CMC sections of regulatory documents, and represent the company as a CMC expert in front of regulatory authorities.
- Establish and maintain detailed project plans, define risks, and optimize timelines and parallel processes.
- Establish phase-appropriate process development and formulation strategies for each drug program and contribute to regulatory strategy and submissions.
- Advanced degree in Chemical or Biological Sciences.
- 8+ years of industry experience.
- Significant experience working with external CROs/CMOs.
- Extensive experience with manufacturing, formulation/drug product development, and analytical development.
- Understanding of cGMP compliance requirements associated with U.S., EU, ICH, and other pertinent regulatory agencies is required.