Scientist I, Process Development
Legend Biotech
June 30, 2026
On-site
Somerset, NJ
Operations
Role Overview
The Scientist I, Process Development (PD) will be responsible for developing, establishing, and optimizing scalable manufacturing processes for Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. Supports development of scalable, cGMP-compliant processes and documentation for novel allogeneic cellular, gene therapeutic, and biological products. Requires prior experience with mammalian cell culture (cell line and primary cell) and process development for cellular/gene therapies.
Key Responsibilities
- Support design of complex process development studies for vector bioprocessing and cell processing workflows.
- Execute bioprocess development studies (bioreactor runs, upstream engineering, downstream processing), document procedures, and interpret results.
- Execute bespoke manufacturing in the GMP suite and document procedures on Master Batch Records (MBRs).
- Author technical protocols, technical reports, SOPs, and MBRs; maintain lab notebooks and manufacturing records.
- Manage equipment and records (maintenance, calibration, cleaning, operation) and maintain lab inventories.
- Provide SME support for manufacturing root cause investigations for Deviations and CAPA.
- Analyze and organize process development/manufacturing data using engineering and statistical tools; communicate clearly.
- Collaborate cross-functionally (EDD, Analytical Development, Material Science) to establish development strategies and supply materials for pre-clinical studies.
- Evenings/weekends as needed per project timelines.
Requirements
- Advanced degree (BS/MS/PhD) in process engineering, immunology, cell biology, or equivalent.
- Experience: BS 3–5 yrs; MS 2–3 yrs; PhD 1–2 yrs in process development of gene/gene-modified products.
- Core background in bioprocessing of biologics/vaccines/viral vectors (incl. viral vectors and cell therapy).
- Hands-on bioreactors (scale down/up) and downstream processing (filtration, chromatography, TFF) for lentivirus/AAV/viral products.
- Experience in cell processing: mammalian cell culture, primary cell processing, cellular expansion.
- Experience authoring SOPs/procedures for unit operations; ability to transfer upstream/downstream processes.
- Detail-oriented; proficient with statistical tools (JMP/GraphPad) and visualization/trending (PowerBI).
- cGMP/FDA guidelines proficiency preferred.
Benefits and Paid Time Off
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; PTO (vacation, personal, sick, floating holidays) and 11 company holidays; other voluntary benefits.
Pay Range (Base Pay)
- $96,267–$126,351 USD.
Please note
- Benefits for permanent full-time employees only; contractors are not eligible.
The Scientist I, Process Development (PD) will be responsible for developing, establishing, and optimizing scalable manufacturing processes for Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. Supports development of scalable, cGMP-compliant processes and documentation for novel allogeneic cellular, gene therapeutic, and biological products. Requires prior experience with mammalian cell culture (cell line and primary cell) and process development for cellular/gene therapies.
Key Responsibilities
- Support design of complex process development studies for vector bioprocessing and cell processing workflows.
- Execute bioprocess development studies (bioreactor runs, upstream engineering, downstream processing), document procedures, and interpret results.
- Execute bespoke manufacturing in the GMP suite and document procedures on Master Batch Records (MBRs).
- Author technical protocols, technical reports, SOPs, and MBRs; maintain lab notebooks and manufacturing records.
- Manage equipment and records (maintenance, calibration, cleaning, operation) and maintain lab inventories.
- Provide SME support for manufacturing root cause investigations for Deviations and CAPA.
- Analyze and organize process development/manufacturing data using engineering and statistical tools; communicate clearly.
- Collaborate cross-functionally (EDD, Analytical Development, Material Science) to establish development strategies and supply materials for pre-clinical studies.
- Evenings/weekends as needed per project timelines.
Requirements
- Advanced degree (BS/MS/PhD) in process engineering, immunology, cell biology, or equivalent.
- Experience: BS 3–5 yrs; MS 2–3 yrs; PhD 1–2 yrs in process development of gene/gene-modified products.
- Core background in bioprocessing of biologics/vaccines/viral vectors (incl. viral vectors and cell therapy).
- Hands-on bioreactors (scale down/up) and downstream processing (filtration, chromatography, TFF) for lentivirus/AAV/viral products.
- Experience in cell processing: mammalian cell culture, primary cell processing, cellular expansion.
- Experience authoring SOPs/procedures for unit operations; ability to transfer upstream/downstream processes.
- Detail-oriented; proficient with statistical tools (JMP/GraphPad) and visualization/trending (PowerBI).
- cGMP/FDA guidelines proficiency preferred.
Benefits and Paid Time Off
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; PTO (vacation, personal, sick, floating holidays) and 11 company holidays; other voluntary benefits.
Pay Range (Base Pay)
- $96,267–$126,351 USD.
Please note
- Benefits for permanent full-time employees only; contractors are not eligible.