Cell Based Potency Assay Jobs in Virginia (NOW HIRING)

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Job Description

Join Us as a Vaccines Laboratory Leader – Drive Innovation in Vaccine Development
The Vaccines Laboratory Leader provides strategic and operational leadership for vaccine-focused laboratory operations, supporting research, development, characterization, and lifecycle management of vaccine products. This role integrates scientific excellence, operational efficiency, regulatory compliance, and cross-functional collaboration to accelerate vaccine programs from early development through commercialization.
The Vaccines Laboratory Leader sets operational standards, develops long-term laboratory strategy, manages budgets and capital investments, and ensures compliance with global regulatory and biosafety requirements. This role may require up to 30% travel.
What You'll Do:
Lead Vaccine Laboratory Operations
Provide strategic and operational leadership across vaccine development laboratories, including antigen discovery, assay development, immunogenicity testing, viral/bacterial characterization, and stability programs.
Drive Scientific & Technical Excellence
Oversee development, qualification, validation, and transfer of analytical methods supporting vaccine drug substance and drug product programs. Ensure scientific rigor and innovation in support of novel vaccine platforms (e.g., mRNA, viral vectors, recombinant proteins, adjuvants).
Integrate Cross-Functional Functions
Partner with Quality, PPI, Automation, Operations and Regulatory Affairs to ensure seamless program execution from early development through commercialization and lifecycle management.
Ensure Regulatory & Biosafety Compliance
 Oversee adherence to global regulatory standards (FDA, EMA, WHO, MHRA, etc.), applicable GxP requirements, and biosafety regulations. Lead inspection readiness efforts and represent laboratory operations during audits and regulatory interactions.
Strategic & Financial Leadership
Develop operating budgets, capital expenditure plans, and long-term forecasts. Optimize laboratory resources, space allocation, and instrumentation to maximize operational efficiency and program success.
Support Business Growth & External Partnerships
Collaborate with Business Development to support new vaccine program opportunities, external partnerships, and technology transfers. Contribute technical expertise during client engagements and due diligence activities.
Talent & Organizational Development
Lead, mentor, and develop high-performing scientific teams. Foster a culture of collaboration, innovation, accountability, and continuous improvement.
Operational Excellence & Continuous Improvement
Establish laboratory goals, KPIs, and performance metrics. Implement process improvements to enhance productivity, data integrity, and regulatory compliance.
Education & Experience Requirements:

• Bachelor’s degree in Microbiology, Immunology, Virology, Biochemistry, Pharmaceutical Sciences, or related life sciences field required; advanced degree (MS, PhD) strongly preferred.

• Extensive experience in vaccine development, biologics, or related pharmaceutical laboratory environments (typically 15+ years).

• Demonstrated experience leading multi-disciplinary laboratory teams supporting vaccine R&D programs.

• 10+ years of progressive leadership and people management experience.

• Strong understanding of vaccine platforms, immunology, and biologics development lifecycle.

Years of experience reflect typical requirements and are not the sole determinant in employment decisions.
Knowledge, Skills, Abilities:

• In-depth knowledge of vaccine development processes, including antigen design, immunogenicity assessment, potency assays, and stability testing.

• Strong expertise in biologics analytical methodologies (e.g., ELISA, neutralization assays, PCR/qPCR, cell-based assays, flow cytometry, viral titration, HPLC, mass spectrometry).

• Comprehensive understanding of global regulatory requirements and biosafety standards (BSL-2/3 as applicable), and regulatory guidelines relevant to vaccine development.

• Experience supporting regulatory submissions (e.g., IND, BLA, MAA) and inspection readiness.

• Proven financial acumen including budgeting, forecasting, and capital planning.

• Strong strategic planning and execution capabilities.

• Experience with technology transfer and scale-up activities.

• Demonstrated success in building, developing, and retaining high-performing scientific teams.

• Excellent communication skills with the ability to present technical strategies to executive leadership and external stakeholders.

• Strong problem-solving skills with a data-driven, innovative mindset.

• Global mindset with experience working across international teams and regulatory environments.

Working Conditions and Environment:

• Work performed in office and laboratory environments, including BSL-2 and/or BSL-3 settings as applicable.

• Routine use of personal protective equipment (PPE) including lab coats, gloves, eye protection, and respiratory protection where required.

• Potential exposure to biological materials, infectious agents, and regulated chemicals in controlled laboratory environments.

• Occasional exposure to temperature-controlled environments (cold rooms, freezers).

• Travel up to 30%, including domestic and occasional international travel.