VP, Analytical and Process Development CMC
One of our key clients, a dynamic and rapidly expanding late-stage gene therapy company, is currently seeking a VP of Technical Operations and CMC. This is an exceptional opportunity to join a company in the late-stage development of their gene therapy indication, where you will play a pivotal role in helping them prepare for launch and commercialization. They are seeking a highly experienced and driven VP of CMC and Technical Operations to lead critical initiatives across their CMC and manufacturing functions, reporting directly to their Chief Technical Officer.
Main Responsibilities:
- Develop and implement strategic plans for product development, analytical development, and manufacturing to support the company's growing gene therapy pipeline. Align departmental goals with overall company objectives and regulatory requirements in collaboration with executive leadership.
- Lead the transfer of analytical methods and processes to both internal and external Quality Control and manufacturing teams. Ensure seamless integration with development projects and mitigate CMC risks throughout the product lifecycle.
- Oversee and integrate cross-functional development projects, ensuring effective collaboration across departments. Support the manufacture and testing of clinical and commercial launch supplies.
- Oversee the development and optimization of gene therapy vectors, formulations, and delivery methods. Ensure robust process development, scale-up, and validation of manufacturing processes in compliance with regulatory guidelines and quality standards.
- Author and review CMC sections of regulatory submissions (BLA, IND, etc.) and work closely with Regulatory Affairs to ensure the timely and accurate submission of documents. Lead CMC activities for regulatory submissions and launch activities.
- Ensure timely characterization of gene therapy products, including potency, purity, and stability testing. Ensure all CMC and manufacturing activities comply with FDA, EMA, and other global regulatory agency requirements.
- Develop and maintain strong relationships with Contract Development and Manufacturing Organizations (CDMOs) and other external partners to ensure the successful execution of development and manufacturing activities.
Qualifications:
- Must have a PhD in a relevant field.
- Over 15 years of relevant experience in CMC and technical operations.
- Experience in leading Analytical and Process Development teams, with hands-on experience also preferred.
- Direct experience in gene therapy development is highly desirable.
- Proven experience as the CMC lead for BLA submissions and successful launch activities.
- Strong understanding of regulatory guidelines and quality standards, including FDA, EMA, and global regulatory requirements.
- Demonstrated leadership and collaboration skills, with the ability to work cross-functionally and drive projects to completion.
Apply today to learn more or drop me an email to ...@barringtonjames.com