Vice President, Pharmaceutical Development & Manufacturing
Our client is a biopharmaceutical company focused on rare diseases. They have asked us to assist them in their search for a Vice President, Pharmaceutical Development & Manufacturing
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Acts as the senior technical leader for CMC activities within the platform, providing guidance to the Platform Head in the buildout of CMC infrastructure.
- Selects, mentors, and develops a high-performance team and a culture of integrity and accountability.
- Drives and guides strategies for upstream and downstream process development, analytical development, and formulation development.
- Leads team accountable for addressing manufacturing issues associated with the therapy’s complete response letter.
- Supports the development strategy and planning for the program and coordinate tactical plans between stakeholders (e.g. Regulatory, Quality, Clinical, Commercial, etc.).
- Manages relationships with CMOs to achieve delivery of objectives and a productive partnership.
- Directs the writing and reviewing of CMC sections for INDs, BLAs, and other regulatory submissions.
- Instills a culture of quality and data management to assure adherence to compliance requirements.
- Requires a Ph.D. in a relevant scientific field such as, Biochemistry, Chemistry, Cell Biology or Molecular Biology.
- Must have a minimum of 15+ years of pharmaceutical industry experience.
- Must have a minimum of 7+ years leading CMC functional areas (bioprocess, analytical, formulation, etc.).
- The proven ability to navigate the complexities of CMC development from project inception through licensure and commercialization is required.
- Requires broad scientific and technical understanding in the areas of process development/drug development.
- Must have expertise in manufacturing biologics and/or complex therapeutics in a highly regulated environment.
- Experience with regenerative medicine is required.
- Requires experience with FDA inspections and compliance requirements for regulatory filing.
- Requires demonstrated excellence in developing, mentoring, and managing talent.
- Thorough understanding of tools and processes to build fit for purpose and scalable systems is required.
- Must have a solid track record of building strong and collaborative cross-functional working relationships with both internal and external stakeholders.
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.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.