Associate Director, Viral Vector Process Development, Upstream

Qualifications

• Education: Advanced degree (PhD) in Biochemical Engineering, Virology,
• Chemical/Biomedical Engineering, Biotechnology, or related field with 6+ years of relevant experience; or MS with 10+ years.
• Experience
• Deep expertise in upstream LVV process development on suspension platforms, including scale translation to clinical/commercial, process characterization, and technology transfer; proven track record advancing programs from research through IND enabling and into late-stage/GMP settings.
• Technical Skills: Mastery of upstream unit operations for LVV in suspension (cell substrate selection and adaptation, transfection/infection strategies, media/feed optimization, bioreactor control, harvest/clarification interfaces) and application of statistical DOE and data analytics.
• GMP Readiness: Practical experience with cGMP manufacturing operations, phase appropriate validation, and contributing to regulatory filings for US and ex-US markets.
• Leadership & Communication: Ability to lead teams, influence in a matrix
• environment, and communicate complex technical concepts to diverse stakeholders; strong troubleshooting and problem-solving skills.
• Tools & Automation: Experience with single-use suspension bioreactors, process automation, PAT, and digital lab systems to accelerate development and ensure reproducibility.
• Preferred Qualifications
• Clinical/Commercial Scale Delivery: Demonstrated success scaling suspension-based LVV processes to clinical and commercial production with sustained performance and continuous improvement.
• Analytical Interface: Familiarity with upstream–analytical linkages (titer, infectivity/potency, residuals/impurities) to guide process decisions and specifications; experience defining process controls for suspension systems.
• Regulatory Contributions: Experience preparing process/manufacturing sections of regulatory submissions and participating in health authority interactions for LVV programs.
• Operational Excellence: Track record implementing Lean practices and robust documentation/knowledge management in PD settings.
• The annual base pay for this position ranges from $138,392.80 - $207,589.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.