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Cell Therapy Process Development Jobs in Somerset, NJ

Catalent, Inc.

Process Engineer MS&T

Princeton, NJ · On-site

S. commercial manufacturing facility for autologous and allogeneic cell therapies. The site is equipped to support the full product lifecycle, including late-stage clinical development, process ...

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Cell Therapy Process Development information

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$35

$52

How much do cell therapy process development jobs pay per hour?

As of Sep 1, 2026, the average hourly pay for cell therapy process development in Somerset, NJ is $35.59, according to ZipRecruiter salary data. Most workers in this role earn between $29.23 and $43.70 per hour, depending on experience, location, and employer.

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 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.

Cell Therapy Process Development jobs near you
Infographic showing various Cell Therapy Process Development job openings in Somerset, NJ as of August 2026, with employment types broken down into 69% Full Time, and 31% Part Time. Highlights an 100% In-person job distribution, with an average salary of $74,022 per year, or $35.6 per hour.

Scientist I, Process Development

Legend Biotech US

Somerset, NJ • On-site

Full-time

Re-posted 23 days ago

Job description

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

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. The candidate will have demonstrated technical experience working in multidisciplinary research and process development labs to define robust manufacturing processes and/or associated analytical systems. This role supports the development of scalable, cGMP-compliant processes and documentation for novel allogeneic cellular, gene therapeutic, and biological products. This position requires prior experience with mammalian cell culture (cell line and primary cell), process development for cellular/gene therapies, and excellent technical, organizational, and interpersonal skills

Key Responsibilities

  • Under the leadership of senior-level technical staff, support the design of complex process development studies focusing on both vector bioprocessing and cell processing workflows.
  • Ability to work within a team to deliver phase-appropriate process development components of projects with scientific excellence and patient-focus according to Technical Development and Company's strategic objectives.
  • Work according to appropriate standards for quality, ethics, health, safety, environmental protection, and information security; participate in activities aligned with organizational workflow and procedures.
  • Ability to execute bioprocess development studies in the lab (including bioreactor runs, upstream engineering, and downstream processing), document the procedure, and interpret process development experiment results.
  • Ability to execute the bespoke manufacturing process in the GMP suite, and document the procedure on Master Batch Records (MBRs) in a GMP-compliant environment.
  • Author technical protocols, technical reports, SOPs, and MBRs for upstream, downstream, and cell therapy manufacturing processes.
  • Ability to maintain accurate and updated lab notebooks and manufacturing records.
  • Work within the team to manage equipment (such as bioreactors and purification systems) and records for maintenance, calibration, cleaning, and operation, and lead the effort to maintain laboratory inventories.
  • Provide technical support and engineering expertise as a Subject Matter Expert (SME) for manufacturing root cause investigations for Deviations and CAPA.
  • Ability to use engineering and statistical tools to analyze and organize process development and manufacturing data with scientific integrity, and in a clear and concise manner.
  • Ability to work collaboratively with the EDD, Analytical Development, Material Science, and other cross-functional teams to support the establishment of development strategies for new biological/cell products and supply materials to support pre-clinical studies and associated activities.
  • Ability to use professional concepts in accordance with company objectives to solve complex bioprocessing problems in creative and effective ways.
  • Evening and weekend work as deemed necessary according to project timeline and culture schedules.

Requirements

  • Advanced degree (BS, MS, PhD) in process engineering, immunology, cell biology, or equivalent. Technical training / certification is desirable.
  • BS with 3-5 years, MS with 2-3 years and PhD with 1-2 years of experience in process development of gene or gene-modified products in a biotech, academic, or pharmaceutical setting.
  • Core engineering background in bioprocessing of biologics, vaccines, and viral vectors (including working with viral vectors and cell therapy).
  • Experience in biotechnology bioprocessing, gene and cell therapy process development, and/or GMP manufacturing.
  • Hands-on experience working with bioreactors (upstream processing, scale down and scale up model) and downstream processing (e.g., filtration, chromatography, TFF) for lentivirus/AAV vectors, viral products, or biological entities.
  • Experience handling the cell processing side for cell therapies, including mammalian cell culture, primary cell processing, and cellular expansion.
  • Proven experience authoring SOPs/procedures for established and new engineering unit operations.
  • Ability to transfer upstream and downstream bioprocesses to internal or external manufacturing sites.
  • Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
  • Ability to work collaboratively with cross-functional engineering, manufacturing, and analytical teams.
  • Detail-oriented with expertise in engineering problem solving and solid decision-making abilities.
  • Proficiency in cGMP and FDA guidelines is preferred.
  • Excellent teamwork, emotional intelligence, and communication skills.
  • Experience using statistical tools to analyze engineering data (JMP, GraphPad, etc.) and using visualization tools (PowerBI) to trend development and manufacturing data.

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