Upstream Process Development Director
Forge Biologics
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Benefits offered by this job
Job summary
Forge Biologics is seeking an Associate Director to lead upstream process development for viral vector production (AAV/LV). You will manage a team of scientists and associates, design experiments, and scale processes for GMP transfer.
Combining technical excellence with leadership, you will drive regulatory readiness, collaborate with MS&T, QC, and Manufacturing, and author critical CMC documents to support global programs.
Qualifications
- Bachelor's degree in Chemical Engineering, Biology, or a related field.
- Proven mammalian suspension cell culture and viral production experience.
- Strong DOE and statistical analysis skills.
- Excellent communication, leadership, and collaboration.
- Experience with technology transfer to GMP manufacturing.
- Experience mentoring junior team members.
Responsibilities
- Lead day-to-day upstream process development operations.
- Manage and mentor scientists and associates.
- Set technical strategy and regulatory alignment with MS&T, QC, and GMP teams.
- Lead cross-functional global program teams and drive tech transfer.
- Authors CMC documents and supports regulatory filings.
- Provide SME guidance on troubleshooting and optimization.
Skills
Education
Tools
Job description
Forge Biologics is seeking an Associate Director to lead upstream process development for viral vector production (AAV/LV). You will manage a team of scientists and associates, design experiments, and scale processes for GMP transfer.
Combining technical excellence with leadership, you will drive regulatory readiness, collaborate with MS&T, QC, and Manufacturing, and author critical CMC documents to support global programs.
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