The Associate Director will play a pivotal role in leading scientific and operational activities to support upstream process development for viral vector production. This position will manage a team of scientists and research associates to design, execute, and optimize upstream processes, ensuring robust scalability and technology transfer into GMP manufacturing. The ideal candidate will combine technical excellence with strong leadership and collaboration skills to drive innovation and efficiency in upstream development.
Responsibilities
Lead day-to-day operations of upstream process development, including experimental design, execution, and data interpretation for viral vector production (AAV and LV); Senior-level technical expert and upstream leader responsible for complex development initiatives; Independently manages multiple programs or initiatives to a high degree of quality, ensuring technical excellence, scientific rigor, and regulatory alignment; Manages and provides mentorship and coaching to scientists and associates, developing technical capabilities and reinforcing a culture of quality, safety, and continuous learning; Sets technical strategy, ensures compliance with regulatory expectations and manufacturing readiness in collaboration with MS&T, QC, and GMP Manufacturing teams, and drives innovation in upstream process design; Authors high-impact CMC documents, supports regulatory filings, and serves as a cross-functional lead in global program teams; Influences team culture through scientific leadership, collaboration, and clear communication; Partners with Downstream, Analytical, and Manufacturing teams to ensure successful process integration and technology transfer; Oversee the development of scalable upstream processes, promoting innovation and process improvements aligned with company goals, staying within timelines and budgets while maintaining scientific rigor and data integrity; Serve as an SME for upstream operations, providing guidance on troubleshooting and optimization
Requirements
Bachelor's degree in Chemical Engineering, Biology, Bioengineering, or a related field; Proven expertise in mammalian suspension cell culture, transfection, and viral production at bench and pilot scales; Strong understanding of DOE methodology and statistical data analysis; Excellent communication, organizational, and leadership skills; Prior experience supporting technology transfer to GMP manufacturing; Experience managing junior team members; Prior project management experience
Nice to have
Master's or Ph.D. in Chemical Engineering, Biology, Bioengineering, or a related field; Experience with rAAV or lentiviral production platforms; Familiarity with cGMP principles and regulatory expectations for biologics; Demonstrated ability to collaborate in a cross-functional matrixed environment; Experience managing senior team members
Benefits
Health, dental and vision insurance from day one with 90% of premiums covered for employee and family; Competitive paid time off plan; 12 weeks of fully paid parental leave; Annual bonus opportunities for all full-time team members; 401(k) with company match; Special employee discounts, including childcare and dependent care savings; Onsite fitness facility at The Hearth; Mental health counseling and financial planning services through the Employee Assistance Program; Employer-paid short and long-term disability coverage; Fully stocked kitchen with free snacks and beverages; Ongoing professional development resources, training, and mentorship programs
Stany Zjednoczone · Columbus
