Vice President/Senior Director, Product Development
Our client is a biotechnology company. They have asked us to assist them in their search for a Vice President/Senior Director, Product Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Designs highly innovative processes and product development strategies to develop cell therapies for xenotransplantation.
- Leads responsibilities for implementing product development and manufacturing strategies.
- Builds core internal capabilities for both clinical and commercial supply.
- Leads collaborations with academic partners.
- Builds quality management programs to ensure PAI readiness and continued GMP compliance for all programs.
- Holds regular interactions with the board of directors, investors, advisors and partners.
- Interacts with global regulatory agencies as well as authors and reviews relevant Pre-IND, IND, and BLA sections.
- Works collaboratively with senior management to conduct due diligence and assess business development.
- An advanced degree in a biomedical, scientific, or engineering field is required.
- At least ten years of manufacturing and product development experience is required, ideally in both clinical and commercial environments.
- Must have a deep knowledge of GLP and GMP practices.
- A strong knowledge of leukapheresis procedures is required.
- Experience in cell therapy or gene therapy is required.
- Experience in the field of xenotransplantation is preferred.
- Must possess excellent leadership abilities in a manufacturing capacity.
- Requires a working knowledge of FDA and EMA regulations, as well as experience in representing the sponsor in front of regulatory agencies.
- Must have a successful track record of submission of INDs, and submission of marketing approval-directed filings (BLAs, NDAs, and MAAs).
- Experience interacting with and managing multiple CDMOs, manufacturing partners and vendors is required.
- Must have experience with technology transfers and scaled processes in both clinical and commercial scopes.
- The ability to collaborate with internal and external stakeholders as well as a diverse workforce within a cross-functional matrix environment is required.
- Must have exceptional organizational, analytical, critical thinking and problem-solving abilities as well as a strong attention to detail.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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