Reporting to the GM and Head of Viral Vector Services (VVS), the Senior Director of Bioprocess Development (BPD) will manage a team of leaders and oversee Process/Analytical Development (Alachua, FL), Process Sciences and Manufacturing Science and Technology (MST) building differentiating expertise and executing client programs to meet their clinical and commercial needs.
The qualified person will oversee the process development strategy for VVS Sciences and actively lead a team of more than 100 employees in Florida and Massachusetts. He/she will provide strong leadership and guidance, along with operational and scientific oversight to Upstream and Downstream PD, Analytical Development, Technical Operations, Process Establishment, Process Characterization, Process Validation, Continued Process Verification, Manufacturing Sciences & Technology, and Technical Transfers for viral vectors that are utilized in cell and gene therapy products. The Sr Director BPD works closely with the site GM's to enhance the scientific operations and will develop and drive the innovation agenda. In addition, he/she will collaborate with the Science and Technology Team (STT) to transfer in new technologies and process/analytical platforms into VVS.
This executive is responsible for setting and delivering BPD revenue/profitability targets and forecasts. The individual is responsible for all aspects of designing, developing and implementing robust analytics and scalable/reproducible manufacturing processes to produce viral vectors suitable for use in clinical trials and commercial production. In addition, this position develops budgets for labor and capital expenditures, and approve, from a delivery perspective, early to late phase/commercial proposals being made to customers.
The Sr. Director, BPD frequently partners with the VVS leadership team particularly around Manufacturing, Quality, EHS, Commercial Ops, and Client Program Management. In addition, this leader interacts directly with our clients and potential clients providing expertise and guidance on programs and helping to resolve escalation issues.
- Lead teams of directors, managers and technical professionals working in Process/analytical development, process sciences and MST.
- Oversee Process Sciences, Process Development and Manufacturing Sciences and Technology laboratories; ensuring operations are safe and efficiently managed
- Works closely with VVS leadership and peer leaders across Thermo Fisher to identify and prioritize opportunities and drive business results
- Change agent: encourages new ideas, processes and approaches. Champions and enables a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication. Embraces and implements practical process improvements (PPI).
- Hire and develop leaders & employees within the department in support of multi-site objectives. Assign work, provide feedback and coaching, shifting priorities and resources, as needed
- Responsible for providing technical leadership to principal scientists, process engineers, scientists, and associates in the laboratories for clinical and commercial stage products.
- Represent the Sciences Teams on CMC teams and sub-teams to coordinate multi-functional activities for clinical and commercial programs
- Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit
- Work with internal stakeholders in Manufacturing, Quality, Client Program Management, etc. to facilitate successful customer management
- Responsible for the development of the PD, PS, and MST strategy, program timelines, and budgets
- Must stay current with relevant technologies and forward thinking to identify new approaches and to represent VVS at industry conferences and to present on our capabilities.
- Ph.D. and post-doctoral experience in Biochemical Engineering, Microbiology, Biochemistry, Cell Biology, and/or molecular biology required
- A minimum of 15+ years hands-on experience in the Science of vaccines and/or biologics, preferably with cell therapy and/or gene therapy product experience.
- Experience in commercializing a biologic product; PPQ through PAI support and CPV, preferably in a proven biopharma organization.
- 10+ years in a PD, PS and/or MS&T or highly technical Leadership role
- Proven leadership aptitude with excellent people management and organizational skills; ability to prioritize and manage through complex processes/projects.
- Strong interpersonal and communication skills, verbal and written.
- 30%+ Travel Required.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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