Scientist I, Process Development
Legend Biotech
August 13, 2026
On-site
Somerset, NJ
Operations
Role Overview
Scientist I, Process Development (PD) for scalable, cGMP-compliant manufacturing processes supporting Legend’s gene and cellular therapy pipeline and first-in-human/new IND products.
Key Responsibilities
- Design and execute complex process development studies for vector bioprocessing and cell processing workflows.
- Execute bioprocess development in the lab (bioreactor runs, upstream engineering, downstream processing) and interpret results.
- Execute GMP manufacturing processes and document procedures on Master Batch Records (MBRs).
- Author technical protocols, technical reports, SOPs, and MBRs for upstream, downstream, and cell therapy manufacturing.
- Maintain accurate lab notebooks and manufacturing records.
- Manage equipment and records (maintenance, calibration, cleaning, operation) and maintain inventories.
- Serve as SME for manufacturing root cause investigations for Deviations and CAPA.
- Analyze and organize process development/manufacturing data using engineering and statistical tools.
- Collaborate cross-functionally (EDD, Analytical Development, Material Science, etc.) to support development strategies and pre-clinical supply needs.
- Support evening/weekend work as required.
Requirements
- Advanced degree (BS/MS/PhD) in process engineering, immunology, cell biology, or equivalent (certification desirable).
- Experience: BS 3–5 yrs; MS 2–3 yrs; PhD 1–2 yrs in gene/gene-modified product process development.
- Core background in bioprocessing of biologics, vaccines, and viral vectors (incl. viral vectors/cell therapy).
- Experience with gene/cell therapy process development and/or GMP manufacturing.
- Hands-on bioreactors (upstream; scale down/scale up) and downstream (filtration, chromatography, TFF) for lentivirus/AAV/viral or biological products.
- Cell processing experience (mammalian cell culture, primary cell processing, cellular expansion).
- Ability to author SOPs and transfer upstream/downstream processes to manufacturing sites.
- Proficiency in cGMP/FDA guidelines preferred; strong communication/teamwork.
- Statistical tools (e.g., JMP, GraphPad) and visualization (e.g., PowerBI) preferred.
Benefits and Paid Time Off
- Medical, dental, vision; 401(k) with match (vests day one); 8 weeks paid parental leave after 3 months; PTO (vacation, personal, sick, floating holidays) and 11 company holidays.
- Base pay range: $96,267–$126,351 (USD).
Scientist I, Process Development (PD) for scalable, cGMP-compliant manufacturing processes supporting Legend’s gene and cellular therapy pipeline and first-in-human/new IND products.
Key Responsibilities
- Design and execute complex process development studies for vector bioprocessing and cell processing workflows.
- Execute bioprocess development in the lab (bioreactor runs, upstream engineering, downstream processing) and interpret results.
- Execute GMP manufacturing processes and document procedures on Master Batch Records (MBRs).
- Author technical protocols, technical reports, SOPs, and MBRs for upstream, downstream, and cell therapy manufacturing.
- Maintain accurate lab notebooks and manufacturing records.
- Manage equipment and records (maintenance, calibration, cleaning, operation) and maintain inventories.
- Serve as SME for manufacturing root cause investigations for Deviations and CAPA.
- Analyze and organize process development/manufacturing data using engineering and statistical tools.
- Collaborate cross-functionally (EDD, Analytical Development, Material Science, etc.) to support development strategies and pre-clinical supply needs.
- Support evening/weekend work as required.
Requirements
- Advanced degree (BS/MS/PhD) in process engineering, immunology, cell biology, or equivalent (certification desirable).
- Experience: BS 3–5 yrs; MS 2–3 yrs; PhD 1–2 yrs in gene/gene-modified product process development.
- Core background in bioprocessing of biologics, vaccines, and viral vectors (incl. viral vectors/cell therapy).
- Experience with gene/cell therapy process development and/or GMP manufacturing.
- Hands-on bioreactors (upstream; scale down/scale up) and downstream (filtration, chromatography, TFF) for lentivirus/AAV/viral or biological products.
- Cell processing experience (mammalian cell culture, primary cell processing, cellular expansion).
- Ability to author SOPs and transfer upstream/downstream processes to manufacturing sites.
- Proficiency in cGMP/FDA guidelines preferred; strong communication/teamwork.
- Statistical tools (e.g., JMP, GraphPad) and visualization (e.g., PowerBI) preferred.
Benefits and Paid Time Off
- Medical, dental, vision; 401(k) with match (vests day one); 8 weeks paid parental leave after 3 months; PTO (vacation, personal, sick, floating holidays) and 11 company holidays.
- Base pay range: $96,267–$126,351 (USD).