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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.
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What cities in Utah are hiring for Cell Therapy Process Development jobs? Cities in Utah 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 Utah as of August 2026, with employment types broken down into 60% Full Time, and 40% Part Time. Highlights an 100% In-person job distribution.

Analytical Scientist

DISCGENICS INC

Salt Lake City, UT • On-site

Full-time

Re-posted 22 days ago

Job description

Welcome to DiscGenics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment.

At DiscGenics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting-edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort.

Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do.

Join us at DiscGenics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past.

Discover more about us at discgenics.com and see how you can contribute to revolutionizing patient care through regenerative therapies.

We are looking for a talented and dedicated Analytical Scientist to join our team! The Scientist/Senior Scientist, Analytical Sciences is responsible for the development, optimization, qualification, validation, and execution of analytical methods supporting raw materials, in-process, intermediate, and finished product testing for cell therapy products. This role plays a key part in advancing analytical strategies from early development through commercialization, ensuring compliance with FDA and ICH guidelines.

The position includes leading and supporting cell-based development (e.g., ELISA, flow cytometry, potency assays), evaluating new analytical technologies, and enabling method transfer to Quality Control and external partners. The role also contributes to regulatory filings through authoring and reviewing technical reports and CMC sections.

This role collaborates cross-functionally with Process Development, Manufacturing, and Quality teams, while supporting a culture aligned with company values.

Essential Duties and Responsibilities

Analytical Development & Execution

  • Design, develop, optimize, qualify, validate, and execute analytical methods for product characterization and release.
  • Lead and/or support development of cell-based bioassays, potency assays, immunophenotyping, and multiplexed protein assays.
  • Perform routine testing to support development studies and clinical batch release.
  • Track, trend, and statistically analyze data to evaluate method performance and support specification setting.

Method Lifecycle & Technology Transfer

  • Advance analytical methods from concept through qualification and transfer to Quality Control and external partners.
  • Apply Quality by Design (QbD) and Design of Experiments (DOE) principles to method development. Support scale-up and commercialization of analytical methods.
  • Manage outsourced testing activities when needed.

Collaboration & Leadership

  • Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams.
  • Present scientific data and serve as subject matter expert (SME) for analytical methods.
  • Lead or mentor junior scientists and assist in training on analytical methods.
  • Support and contribute to departmental and organizational initiatives.

Laboratory Operations

  • Maintain, calibrate, and operate laboratory equipment and instrumentation.
  • Ensure proper documentation and organization or experimental data.
  • Participate in equipment qualification and upkeep.

Additional Responsibilities

  • Contribute to risk assessments, comparability studies, and specification justifications.
  • Perform other duties as required.

Education & Experience

  • Bachelor’s degree in biological sciences, biochemistry, chemistry, cell biology, or a related field with 7-10+ years of relevant industry experience, OR Master’s degree in a related field with 5-8+ years of experience, OR PhD in a related field with 2-5+ years of experience.
  • 10+ years of experience preferred, particularly within GMP/CMC or other regulated environments and spanning development through commercialization.
  • Experience supporting clinical and commercial development of pharmaceutical, biological, or cell therapy products, including scale-up to commercialization.
  • Hands-on experience with analytical method development (e.g., immunoassays, multi-parameter flow cytometry, cell-based potency assays) in a QC or regulated setting preferred.

Working Conditions:

Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.

Must be able to lift and carry up to 20 pounds.

Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.

Disclaimer:

Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.