Director, Molecular Biology & Virology
About The Position
The Director, Molecular Biology and Virology will be responsible for overall scientific, operational, and strategic leadership of Molecular Biology and Virology laboratory functions. This role leads multidisciplinary scientific teams supporting biologics, cell and gene therapies, and advanced therapy medicinal products (ATMPs) across regulated and non-regulated environments. The Director will provide subject matter expertise across molecular and virology-based assays, oversee assay development and validation activities, ensure compliance with applicable regulatory requirements, and serve as a key scientific and operational partner to Quality, Business Development, Project Management, and clients. This position is accountable for departmental performance, client satisfaction, resource planning, and contribution to business growth.
Requirements
- Subject matter expertise across molecular and virology-based assays
- Oversee assay development and validation activities
- Ensure compliance with applicable regulatory requirements
- Serve as a key scientific and operational partner to Quality, Business Development, Project Management, and clients
- Accountable for departmental performance, client satisfaction, resource planning, and contribution to business growth
- Leadership and management of laboratory operations, including personnel, equipment, space, and operating resources
- Lead and mentor scientific teams
- Development, optimization, qualification, validation, and transfer of molecular biology and virology assays
- Troubleshoot complex scientific and technical challenges
- Ensure on-time delivery of high-quality analytical results
- Oversee regulated bioanalysis review and approval of data, reports, and technical documentation
- Ensure strict adherence to applicable SOPs, HSE requirements, GLP, and cGMP regulations
- Partner closely with Quality Assurance to manage deviations, non-conformances, OOS, change controls, method validations, and audit readiness
- Support and lead client interactions, including scientific consultation, proposal development, protocol review, technical discussions, and participation in audits and regulatory inspections
- Contribute to departmental forecasting, budgeting, and long-term equipment and capacity planning
- Represent the Molecular Biology & Virology function in internal leadership forums and externally with clients and regulatory agencies
- Identify and implement continuous improvement initiatives
Nice To Haves
- qPCR and ddPCR
- Viral genome and residual host cell DNA assays
- Infectious titer assays (e.g., TCID50)
- rcAAV and other viral vector–related assays
- Next Generation Sequencing Subject Matter Expert
Responsibilities
- Provide overall leadership and management of Molecular Biology and Virology laboratory operations, including personnel, equipment, space, and operating resources.
- Lead and mentor scientific teams responsible for the development, optimization, qualification, validation, and transfer of molecular biology and virology assays, including but not limited to: qPCR and ddPCR, Viral genome and residual host cell DNA assays, Infectious titer assays (e.g., TCID50), rcAAV and other viral vector–related assays, Next Generation Sequencing Subject Matter Expert
- Serve as the Subject Matter Expert (SME) for molecular biology and virology technologies, troubleshooting complex scientific and technical challenges as needed.
- Ensure on-time delivery of high-quality analytical results consistent with client expectations, regulatory requirements, and contractual obligations.
- Oversee regulated bioanalysis review and approval of data, reports, and technical documentation.
- Ensure strict adherence to applicable SOPs, HSE requirements, GLP, and cGMP regulations.
- Partner closely with Quality Assurance to manage deviations, non-conformances, OOS, change controls, method validations, and audit readiness.
- Support and lead client interactions, including scientific consultation, proposal development, protocol review, technical discussions, and participation in audits and regulatory inspections.
- Own and contribute to departmental forecasting, budgeting, and long-term equipment and capacity planning.
- Represent the Molecular Biology & Virology function in internal leadership forums and externally with clients and regulatory agencies.
- Identify and implement continuous improvement initiatives to enhance efficiency, data integrity, and scientific excellence.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
