Vice President, Manufacturing/CMC
Our client is a late-stage clinical biotechnology company. They have asked us to assist them in a search for a Vice President, Manufacturing/CMC.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Establishes and oversees pharmaceutical development strategy and tactical implementation plans for phase-appropriate formulation and manufacturing deliverables. Enables timeline execution of product development plans and corporate goals.
- Is responsible for building the internal CMC function and identifying and managing key external CMO partners.
- Leads and manages the Manufacturing and Development team.
- Develops, refines, and ensures compliance with GMP and relevant regulations in US and EU in partnership with Regulatory, QA, and senior management.
- Effectively manages multiple vendors.
- Maintains knowledge of current best manufacturing practices and regulatory guidance and regulations.
- Leads content development for BLAs and INDs for the company’s research candidates as well as potential future international regulatory filings in collaboration with other functions.
- Builds and manages relationships with other discipline heads and key external partners.
- Is responsible for the development and oversight of scale-up and analytical testing of drug substance (API) and drug product (DP) production for preclinical safety/clinical testing and commercialization.
- Contribute to the Research and Development Strategy as a member of the Research and Development Leadership Team.
- A PhD is preferred. A Master’s degree with extensive industry experience in manufacturing/CMC will be considered.
- Must have at least 15 years of experience in manufacturing in the biotech or pharmaceutical industry.
- Extensive experience with the development, optimization and scale-up of manufacturing processes for biologic therapeutics is required. Formulation development expertise is highly desired. Experience with therapeutic proteins is desired.
- Requires leadership and management experience with the proven ability to build a team, coach and motivate employees, set priorities, and effectively make decisions.
- Must have end to end drug development and commercialization experience, with prior experience leading the CMC discipline thorough successful IND and BLA or NDA submissions and approvals, product launch and commercial stage manufacturing and supply chain.
- Must have prior experience managing multiple functions.
- Must have hands on experience in oversight and management of CMC activities at CMOs and partner facilities.
- Requires the ability to set up supply chain strategy and collaborate on multiple process development issues.
- Must have strong analytical and problem-solving skills, with ability to ‘troubleshoot’ in all areas of CMC.
- Requires a solid understanding of FDA and EMA regulatory guidance/requirements as well as experience with authoring regulatory submissions. The demonstrated ability to represent the company at regulatory meetings is required.
- Thorough knowledge of GMP requirements, and basic familiarity with GLP/GCP is required.
- Must have experience in the implementation of GMP QMS, quality oversight/release requirements in US and EU, root cause analysis, and CAPA implementation.
- Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills are essential.
- The ability to think, plan, and influence strategically and diplomatically on the process development priorities across multiple projects is necessary.
- Must be a leader willing to be both a “coach and a player”.
- Must be willing to travel domestically and internationally as needed.
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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