Director, Molecular Biology & Virology

Position Overview

JOB DESCRIPTION

Located at our Large Molecule headquarters in RTP, North Carolina 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.

Critical Performance Areas

• 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.
  

Responsibilities

Essential Job Functions

• Provide scientific leadership in molecular biology and virology methodologies used in CMC characterization, release testing, and process development.
• Interpret and critically evaluate complex data sets, providing scientific insight and clear recommendations to internal stakeholders and clients.
• Drive innovation and adoption of emerging technologies, automation, and best practices within molecular biology and virology laboratories.
• Ensure effective training, performance management, and professional development of scientific staff.
• Collaborate with cross-functional teams, including Project Management, Quality, Regulatory, and Business Development, to support program execution and business growth.
• Accurately project resource needs and manage departmental capacity to meet current and future demand.
• Maintain effective use of LIMS and laboratory systems to ensure data integrity and operational efficiency.
  
  

Requirements

QUALIFICATIONS

• B.S. in Molecular Biology, Virology, Microbiology, Biochemistry or related field with 20 years of relevant industry experience; or MS in Molecular Biology, Virology, Microbiology, Biochemistry or related field with 15 years of relevant industry experience; or Ph.D. in Molecular Biology, Virology, Microbiology, Biochemistry or related field with 10 years of relevant industry experience.
• Minimum of 10 years experience in Pharmaceutical, CDMO, CRO, or cGMP required.
• Demonstrated leadership experience managing scientific teams and complex programs in a CRO, CDMO, cGMP, or biopharmaceutical environment required.
• Proven record of successful client consultation and project management.
• Strong expertise in molecular biology and virology assay development, validation, and regulatory applications.
• Next Generation Sequencing experience required.
• Proven ability to support client consultation, proposal development, and project execution.
• Experience with advanced therapy modalities (e.g., viral vectors, CGT, vaccines) strongly preferred.
  
  

Other Desired Skills/Abilities

• Excellent written and verbal communication skills.
• Financial and operational acumen, including budgeting and resource management.
• Ability to work independently while collaborating effectively across functions.
• Comfortable representing scientific functions during audits, inspections, and client meetings.
• Experience in a site startup.
• Experience with LIMS implementation, optimization, or integration in Molecular Biology and Virology laboratories.
  
  

NOTENote: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

DisclaDisclaimer:  Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.