Sr. Director / Vice President of Analytical Development, Cell & Gene Therapy
Reporting to the Senior Vice President of Testing and Analytical Services, the Senior Director of Analytical Development will provide leadership for the development and execution of complex analytical assays for Cell and Gene Therapy products. The Senior Director will lead the team on technology and assay development, client assay transfers, assay validation, and deliverables related to cell and gene therapy analytical programs. The ideal candidate has experience with team leadership, demonstrated skillset and knowledge of analytical development, with a proven track record in molecular / virology and cell-based methods that support cell and gene therapy products in the areas of the process, characterization, and release testing. The incumbent will also be responsible for driving the strategy and evaluation of new analytical technologies and techniques to serve our clients, bringing cell and gene therapies from bench to bedside.
- Leads the technical team responsible for the successful design, execution, analysis, and documentation of programs that will be built to develop analytical assays for Cell and Gene Therapy Products
- Provides technical and scientific leadership to the team responsible for the development and validation of analytical essays
- Responsible for evaluating and implementing novel analytical technologies and assays with the
- Testing Business Unit Leadership team
- Trend Technical performance of assays and participate in assay improvements, client investigations, and regulatory support
- Review and approve technical documents including standard operating procedures, test methods, and technical reports
- Provide technical leadership, guidance, and training to the team as defined in the Good Manufacturing Practice (GMP) regulations.
- Develop and maintain systems that ensure the technical and regulatory competency of Scientists and staff.
- Support business with scientific and technical input and participation.
- Ensure all team members are providing the highest level of customer service to clients.
- Monitor requests for additional information (AIs) from regulatory bodies received through Sponsors and ensure test protocols and reports conform to the most current regulatory guidelines and expectations.
- Evaluate risks and opportunities with Sr. Management and drive strategic outcomes for the business.
- Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems. Conducts employee performance appraisals in a timely and objective manner. Monitors the growth and career development of direct reports.
- Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
- Lead, coach, and mentor a team of up to 50 scientists
- Continuously reach out to academia, conferences, literature to stay ahead of developments in the space of AD
- Monitor the effective implementation of appropriate EHS and Biosafety procedures and provide for their updating in line with SOPs.
- Where required, and in partnership with QA/Regulatory Affairs, meet with relevant Regulatory Bodies to resolve any compliance issues or help with any new business requirements that potentially impact the accreditation or compliance status.
- Represent the Company to customers, visitors, community organizations, local/state and governmental authorities, unions, industry associations, and regulatory agencies.
- Perform all other related duties as assigned by the SVP of Testing and Analytical Services.
- M.S. degree in cellular biology, virology, molecular biology, analytical or relevant scientific discipline with 15+ years of relevant experience or Ph.D. in relevant field with 8+ years of experience in cellular biology, virology, molecular biology, analytical and experience in leadership or equivalent capacity is preferred.
- Proven track record in assay development, including experimental design, execution, and evaluation
- Experience qualifying and transferring analytical assays to QC GMP lab setting * Knowledge of and experience with Cell and/or Gene Therapy products and/or programs
- Experience with cell-based assays, ELISAs, virology based methods, flow cytometry, and qPCR/ddPCR
- Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects
- Strong communication skills in technical writing and oral presentation
- Excellent written and verbal communication skills.
- Motivation and ability to solve complex problems.
- A systematic approach to tasks.
- Theoretical and practical knowledge of analytical techniques.
- The ability to develop and validate new methods.
- Numerical and analytical ability.
- Computer literate