Vice President, Manufacturing & Operations
Our client is a biotechnology company. They have asked us to assist them in a search for a Vice President, Manufacturing & Operations
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Builds and maintains strong, transparent, collaborative relationships within the organization, and with the contract manufacturing organizations (CMO) and partners.
- Partners with the regulatory group to develop the CMC regulatory strategy,
- Identifies key issues and remediation activities needed throughout the project life cycle and communicates with project teams and appropriate management levels.
- Ensures all CMC related regulatory deliverables associated with each project are completed within defined timelines and meet regulatory guidelines.
- Provides a global effective strategy to optimize manufacturing sites and CMOs throughout, efficiencies, and improved batch success rates.
- Supports expansion and growth of future commercial campaigns.
- Oversees the development and maintenance of the budget for assigned program activities, including preparing cost estimates to ensure programs are delivered on schedule.
- Directs drug substance product process development and supply chain operational activities for the company’s biologics programs.
- Works closely with external CMOs, collaborators, and partners to rapidly advance programs to key decision points.
- Collaborates in the evaluation, selection and managing of contract service providers.
- Enhances scientific leadership in resolving manufacturing process and product issues and accelerates sharing of best practices across the organization.
- Provides strategic direction for product supply and oversees the rollout of such a strategy to ensure no missed doses in clinic or commercial spaces.
- Leads the tech transfer of new processes from development into manufacturing sites and transfer of exiting processes between sites and CMO’s.
- Contributes to the generation and protection of company intellectual property.
- A PhD or equivalent in biochemistry, pharmaceutical sciences, chemical engineering or closely related science is required. Master's candidates with appropriate experience will be considered.
- At least 15 years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience is required.
- Must have at least 5 years of leadership experience in biologics process development with a focus on late stage, Phase 3 or manufacturing leadership roles.
- Strong expertise and understanding of global CMC regulations, processes, and issues in biologic drug development are required.
- Must have leadership experience in managing diverse project activities with contract CMO facilities at different global locations.
- Experience leading diverse, multi-cultural technical teams within technical area of responsibility is required.
- Requires experience in support of regulatory submissions.
- Experience contributing to BLA regulatory filings is required.
- Requires experience with clinical and commercial supply management, process scale-up and technology transfers, cGMPs, ICH guidelines, as well as the CMC content of global regulatory submissions.
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 and Forbes' list of Top 200 Best Executive Recruiting Firms.