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Cell Therapy Process Development Jobs in Missouri

AMRI

Process Chemist II

Springfield, MO · On-site

... contract development and manufacturing organization (CDMO) with over 30 years of experience ... At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ...

Curia, Inc.

Process Chemist II

Springfield, MO · On-site

... contract development and manufacturing organization (CDMO) with over 30 years of experience ... At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ...

Washington University of St. Louis

$18.77 - $31.94/hr

This position is part of a translational cell therapy program focused on advancing next-generation ... Assists in the training and development of technicians, acting as a group leader. * Performs other ...

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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 Missouri? For Cell Therapy Process Development jobs in Missouri, the most frequently searched job titles are:
What job categories do people searching Cell Therapy Process Development jobs in Missouri look for? The top searched job categories for Cell Therapy Process Development jobs in Missouri are:
Cell Therapy Process Development jobs near you
Infographic showing various Cell Therapy Process Development job openings in Missouri as of August 2026, with employment types broken down into 70% Full Time, and 30% Part Time. Highlights an 100% In-person job distribution.

Senior Director, Regulatory Affairs Strategy - Cell Therapy

Jobtailor

California, MO • On-site

$180 - $240/hr

Other

Posted 4 days ago

Job description

  • Set the global regulatory vision for pioneering cell therapies
  • Own the end-to-end global regulatory strategy for high-complexity cell therapy programs
  • Lead strategy for agency meetings, information requests, and expedited pathway designations
  • Shape development and commercialization plans
  • Oversee all regulatory deliverables and milestones
  • Build strong relationships with regulatory stakeholders
  • Lead a Global Regulatory Strategy Team for specific indications/programs
  • Maintain accountability for product maintenance and compliance activities
Requirements
  • An advanced degree in a science related field
  • Seven to ten years of experience and/or appropriate knowledge/experience
  • Demonstrated success in cell therapy regulatory strategy
  • Deep understanding of global regulatory science and integration with program strategy
  • Long standing experience of overall drug/biologic development processes
  • Experience with product development in oncology, autoimmune, rare diseases, neurology
  • Proven experience leading regulatory and cross-functional teams
  • Excellent oral, written, and presentation skills
  • Strong organizational skills
  • Ability to work in a fast-paced environment
Core Competencies

Expertise in global regulatory strategy for cell therapies, with a strong focus on compliance, product development, and cross-functional team leadership. Proven ability to navigate complex regulatory environments and build relationships with stakeholders in the biotechnology sector.

Highest-signal resume keywords
  • Cell Therapy Regulatory Strategy
  • Global Regulatory Science
  • Drug/Biologic Development Processes
  • Regulatory Team Leadership
  • Cross-Functional Collaboration
Hard Skills
  • Regulatory Strategy Development
  • Regulatory Deliverables Oversight
  • Product Maintenance Compliance
  • Agency Meeting Strategy
  • Expedited Pathway Designation
Soft Skills
  • Excellent Oral Communication
  • Strong Organizational Skills
  • Presentation Skills
Certifications & Qualifications
  • Advanced Degree in Science
Industry Keywords
  • Oncology
  • Autoimmune Diseases
  • Rare Diseases
  • Neurology
  • Regulatory Stakeholder Engagement
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