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Cell Therapy Process Development Jobs in New York

Actalent

Cell & Gene Therapy Associate

Allendale, NJ

Cell & Gene Therapy Associate * The Cell & Gene Therapy Associate supports clinical manufacturing ... Process cultures, cryopreserve, and manipulate cell products using aseptic technique to maintain ...

Actalent

Cell & Gene Therapy Associate

Allendale, NJ

Cell & Gene Therapy Associate * The Cell & Gene Therapy Associate supports clinical manufacturing ... Process cultures, cryopreserve, and manipulate cell products using aseptic technique to maintain ...

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Cell Therapy Process Development information

What are the key skills and qualifications needed to thrive as a cell therapy process development professional?

To thrive in Cell Therapy Process Development, you need a solid background in cell biology, biotechnology, or a related field, often supported by a relevant degree and experience with cell culture techniques. Familiarity with bioprocessing equipment, Good Manufacturing Practice (GMP) regulations, and analytical tools such as flow cytometry and PCR is typically required. Strong problem-solving skills, attention to detail, and effective teamwork enhance performance in this collaborative and innovative environment. These competencies ensure the safe and efficient development of cell therapies, meeting rigorous quality standards and advancing clinical applications.

What are some typical challenges faced by professionals in cell therapy process development, and how are they addressed?

Professionals in Cell Therapy Process Development often encounter challenges such as scaling up production processes from laboratory to clinical or commercial scale while maintaining product quality and consistency. Additional hurdles include adhering to strict regulatory requirements and managing complex collaborations across cross-functional teams, like quality assurance, regulatory affairs, and manufacturing. These challenges are typically addressed through rigorous process optimization, thorough documentation, and ongoing communication with stakeholders to ensure that all aspects of the process meet industry standards and regulatory expectations.

What is the difference between Cell Therapy Process Development vs Cell Therapy Manufacturing Specialist?

AspectCell Therapy Process DevelopmentCell Therapy Manufacturing Specialist
CredentialsTypically requires a degree in biology, biochemistry, or biomedical engineering; certifications in GMP or cell therapy are commonSimilar credentials; often holds degrees in related fields and GMP certifications
Work EnvironmentResearch labs, development facilities, early-stage process optimizationManufacturing plants, production floors, quality control labs
Industry UsageFocuses on developing and optimizing cell therapy processesInvolved in large-scale production and process execution

Cell Therapy Process Development professionals focus on designing and refining cell therapy procedures, while Cell Therapy Manufacturing Specialists handle the production and quality assurance in manufacturing settings. Both roles require similar educational backgrounds and certifications but differ mainly in their work environment and specific responsibilities.

What is cell therapy process development?

Cell Therapy Process Development refers to the design, optimization, and scaling up of manufacturing processes for cell-based therapies, such as CAR-T cells or stem cell products. Professionals in this field work on translating laboratory research into reproducible, efficient, and safe production methods that meet regulatory standards. This involves working with cell culture techniques, bioreactors, quality control, and process validation to ensure that therapies can be produced consistently for clinical and commercial use. The goal is to develop robust processes that deliver safe and effective cell therapies to patients.
What are popular job titles related to Cell Therapy Process Development jobs in New York? For Cell Therapy Process Development jobs in New York, the most frequently searched job titles are:
What job categories do people searching Cell Therapy Process Development jobs in New York look for? The top searched job categories for Cell Therapy Process Development jobs in New York are:
What cities in New York are hiring for Cell Therapy Process Development jobs? Cities in New York with the most Cell Therapy Process Development job openings:
Cell Therapy Process Development jobs near you
Infographic showing various Cell Therapy Process Development job openings in New York as of August 2026, with employment types broken down into 70% Full Time, and 30% Part Time. Highlights an 100% In-person job distribution.

Principal Scientist, Upstream Process, Process Development

Legend Biotech US

Somerset, NJ • On-site

Full-time

Re-posted 25 days ago

Job description

Legend Biotech is seeking a Principal Scientist, Lentivirus Upstream Process Development as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Principal Scientist, Lentivirus Upstream Process Development, will be a key technical leader responsible for designing, optimizing, and scaling upstream production processes for lentiviral vectors (LVV) within our innovative pipeline. This role focuses on delivering high-quality, high-titer vector products to support LVV generation and other advanced cell therapy programs. The successful candidate will drive scientific excellence in upstream processing (USP)-including seed train optimization, mammalian cell culture (HEK293 and HEK293T), large-scale transient transfection, and bioreactor scale-up and scale-down model-ensuring processes are robust, scalable, and phase-appropriate for GMP manufacturing. This position demands a blend of hands-on technical mastery and strategic thinking to accelerate timelines while maintaining a patient-focused approach

Key Responsibilities

  • Design and execute highly efficient upstream production strategies for lentiviral vectors.
  • Direct the development and optimization of upstream processes including but not limited to: seed train expansion, suspension mammalian cell culture (HEK293/HEK293T), plasmid transient transfection optimization, and feed batch/perfusion bioprocessing in stir-tank and rocker bioreactors.
  • Establish and validate robust bioreactor scale-up and scale-down models to ensure process comparability and predictability across different manufacturing scales.
  • Direct the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
  • Provide hands-on training as needed.
  • Lead the execution of study protocols to define operating parameters, feeding strategies, and performance limits; implement state-of-the-art knowledge management for USP data.
  • Communicate the potential for issues and delays along with solutions and mitigation approaches.
  • In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical leads, identify project acceleration opportunities.
  • Leverage advanced science and technology to maximize vector titer, specific productivity, and quality, identifying creative solutions to define unknowns in the viral vector production field.
  • Guide a team of scientists in the execution of project-specific activities, fostering a culture of transparency, scientific rigor, and continuous improvement.
  • Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions (IND).
  • Work closely with Downstream Process Development and Analytical Development teams to ensure integrated and holistic process outcomes.
  • Tech transfer process to/from other Legend sites or CDMOs.
  • Resolve conflict and proactively identify/address performance issues.
  • Ensure compliance with regulatory requirements.

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 within a biotech or pharmaceutical setting
  • Deep technical hands-on experience in mammalian cell culture (HEK293, HEK293T), seed train expansion, feeding strategy and transient transfection optimization specifically 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.
  • Deep knowledge and hands-on experiences in cell and lentiviral vector technologies within the current emerging field
  • Strong knowledge in engineering modeling, mass transfer, and bioprocess optimization.
  • Excellent leadership, emotional intelligence, and communication skills; ability to maintain composure and strategic focus during challenging development timelines.
  • Creative, strategic thinking.
  • Strong troubleshooting skills
  • Preferred experience in handling large-scale (>50L, e.g., 200L/500L) upstream bioreactor processes.
  • Language(s): English. Mandarin is a plus.

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