Principal Scientist, Lentivirus Upstream Process Development
Мэтч & Сопровод
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Описание вакансии
TL;DR
Principal Scientist, Lentivirus Upstream Process Development (Lentivirus/Upstream Process Development): Designing, optimizing, and scaling upstream production processes for lentiviral vectors to deliver high-quality, high-titer vector products with an accent on GMP-ready upstream processing, bioreactor scale-up/scale-down modeling, and technology transfer. Focus on solving complex process comparability challenges across manufacturing scales while maintaining phase-appropriate, patient-focused execution.
Location: Somerset, New Jersey, United States
Salary: $146,410 - $192,164 USD (base pay)
Company
is a global biotechnology company developing advanced cell therapies, including lentiviral vector-based immunotherapies.
What you will do
- Design and execute upstream production strategies for lentiviral vectors, including seed train expansion, HEK293/HEK293T suspension cell culture, and transient transfection optimization.
- Develop and optimize feed batch/perfusion bioprocessing in stir-tank and rocker bioreactors.
- Build and validate bioreactor scale-up and scale-down models to ensure process comparability and predictability across manufacturing scales.
- Translate bench-scale processes to GMP manufacturing, supporting technology transfer and troubleshooting during clinical production runs.
- Lead study protocol execution (operating parameters, feeding strategies, performance limits) and manage USP knowledge for upstream process data.
- Author and review technical documents (development reports, SOPs, and IND CMC sections) and collaborate with downstream and analytical development teams.
Requirements
- Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Virology, Molecular Biology, or a related field.
- 8+ years (PhD) or 10+ years (MS) of experience in process development or manufacturing in a biotech or pharmaceutical setting.
- Deep hands-on experience with mammalian cell culture (HEK293, HEK293T), seed train expansion, feeding strategy, and transient transfection optimization for viral vectors (lentivirus preferred).
- Proven expertise in developing and implementing bioreactor scale-up and scale-down models.
- Strong understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials.
- English: required; Mandarin is a plus.
Culture & Benefits
- Medical, dental, and vision insurance plus a 401(k) retirement plan with company match.
- Eight (8) weeks of paid parental leave after three (3) months of employment.
- Paid time off including vacation, personal time, sick time, floating holidays, and eleven (11) company holidays.
- Additional voluntary benefits such as flexible spending and health savings accounts, life/AD&D insurance, and disability coverage.
- Base pay range is for permanent full-time employees; contractors are not eligible for benefits.
Hiring process
- Interviews to assess technical depth in upstream lentiviral vector process development and GMP/CMC experience.
- Evaluation of leadership, communication, and ability to troubleshoot and drive process improvements under development timelines.
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