Associate Director, PD Upstream
About The Position
The Associate Director leads scientific and operational activities supporting upstream process development for viral vector production. The role manages a team of scientists and research associates who design, execute, and optimize upstream processes, ensuring scalability and technology transfer into GMP manufacturing. The Associate Director provides senior technical leadership for complex development initiatives, manages multiple programs, and promotes technical excellence, scientific rigor, regulatory alignment, quality, safety, and continuous learning. The position sets upstream technical strategy, oversees development of scalable processes, supports regulatory filings, and authors high-impact CMC documents. It collaborates with MS&T, QC, GMP Manufacturing, Downstream, Analytical, and Manufacturing teams to support process integration and technology transfer. The role also serves as a subject matter expert in upstream operations, providing troubleshooting and optimization guidance while advancing innovation and process improvements within timelines and budgets. The position works in both laboratory and typical office environments. Physical demands vary by task and include extended periods standing or sitting, wearing task-appropriate personal protective equipment, and working in confined spaces such as clean rooms or laboratories. The employee must be able to identify small visual details, distinguish colors, and accurately identify objects within a specific area.
Requirements
- Bachelor’s degree in Chemical Engineering, Biology, Bioengineering, or a related field.
- 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 Haves
- 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.
Responsibilities
- Lead day-to-day upstream process development operations, including experimental design, execution, and data interpretation for AAV and lentiviral production.
- Serve as a senior technical expert and upstream leader for complex development initiatives.
- Independently manage multiple programs or initiatives while maintaining high quality, technical excellence, scientific rigor, and regulatory alignment.
- Manage, mentor, and coach scientists and associates; develop their technical capabilities and reinforce quality, safety, and continuous learning.
- Set technical strategy and ensure regulatory alignment and manufacturing readiness in collaboration with MS&T, QC, and GMP Manufacturing teams.
- Drive innovation in upstream process design.
- Author high-impact CMC documents, support regulatory filings, and serve as a cross-functional lead in global program teams.
- Influence team culture through scientific leadership, collaboration, and clear communication.
- Partner with Downstream, Analytical, and Manufacturing teams to enable process integration and technology transfer.
- Oversee development of scalable upstream processes and promote innovation and process improvements aligned with company goals, timelines, budgets, scientific rigor, and data integrity.
- Serve as an upstream operations subject matter expert and provide guidance on troubleshooting and optimization.
Benefits
- Health, dental, and vision insurance effective on the first day, with 90% of premiums covered for the employee and family.
- Competitive paid time off plan.
- 12 weeks of fully paid parental leave.
- Annual bonus opportunities for full-time team members.
- 401(k) with company match.
- Employee discounts, including childcare and dependent care savings.
- Onsite fitness facility.
- 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.
- Professional development resources, training, and mentorship programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
