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Cell Therapy Process Development Cmc Director Jobs

BrainChild Bio, Inc.

... development and lifecycle management of its cell therapy programs. This role serves as the CMC ... Drive continuous improvement of CMC Quality systems, processes, and organizational capabilities to ...

Legend Biotech USA, Inc.

Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy ... Direct the translation of bench-scale processes to GMP manufacturing by simulation plus wet lab ...

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Cell Therapy Process Development Cmc Director information

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How much do cell therapy process development cmc director jobs pay per year?

As of Sep 10, 2026, the average yearly pay for cell therapy process development cmc director in the United States is $123,000.00, according to ZipRecruiter salary data. Most workers in this role earn between $93,500.00 and $141,000.00 per year, depending on experience, location, and employer.

What does a cell therapy process development CMC director do?

A Cell Therapy Process Development CMC (Chemistry, Manufacturing, and Controls) Director oversees the development and optimization of manufacturing processes for cell therapy products. They ensure that all processes comply with regulatory standards and are scalable for commercial production. This role involves leading cross-functional teams, managing technology transfers, and collaborating with quality, regulatory, and research departments to ensure the safety, efficacy, and quality of cell-based therapies. The CMC Director is critical in guiding products from early development through to clinical trials and eventual market approval.

What are the primary challenges faced by a cell therapy process development CMC director during technology transfer to manufacturing?

A Cell Therapy Process Development CMC Director often encounters challenges such as ensuring process scalability, maintaining product quality, and addressing regulatory requirements during technology transfer to manufacturing. Bridging gaps between development and manufacturing teams requires strong cross-functional communication and problem-solving skills. Additionally, adapting processes to fit existing manufacturing platforms while minimizing risks of variability or contamination is a key focus. Successful directors proactively coordinate with quality, regulatory, and operations teams to ensure a smooth and compliant transfer.

What are the key skills and qualifications needed to thrive as a cell therapy process development CMC director, and why are they important?

To excel as a Cell Therapy Process Development CMC Director, you need advanced expertise in cell therapy manufacturing, process development, and regulatory requirements, typically backed by a Ph.D. or equivalent in a life sciences field. Familiarity with GMP regulations, bioprocessing technologies, and quality management systems, as well as experience with IND/BLA submissions, is essential. Strong leadership, strategic thinking, and excellent cross-functional communication skills set top candidates apart. These skills ensure the successful development, scale-up, and regulatory approval of safe and effective cell therapy products in a highly regulated environment.

What is the difference between Cell Therapy Process Development Cmc Director vs Cell Therapy Process Development Scientist?

AspectCell Therapy Process Development Cmc DirectorCell Therapy Process Development Scientist
CredentialsAdvanced degree (PhD, MSc) in life sciences, extensive industry experienceMaster's or PhD in relevant field, specialized training
Work EnvironmentLeadership role overseeing teams and projects, strategic planningHands-on laboratory work, experimental design, data analysis
Industry UsageSenior-level position in biotech/pharma companies, responsible for CMC strategiesResearch and development teams, early-stage process development

The Cell Therapy Process Development Cmc Director focuses on strategic leadership, regulatory compliance, and overseeing process development teams. In contrast, the Cell Therapy Process Development Scientist is more involved in experimental work, process optimization, and data collection. Both roles require relevant scientific credentials, but the director position emphasizes management and strategic planning within the industry.

What are popular job titles related to Cell Therapy Process Development Cmc Director jobs?

For Cell Therapy Process Development Cmc Director jobs, the most frequently searched job titles are:

Infographic showing various Cell Therapy Process Development Cmc Director job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 82% Full Time, 14% Part Time, and 2% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $123,000 per year, or $59.1 per hour.

Senior Scientist, Process Development

Cambridge, MA • On-site

Scorpion Therapeutics
51 - 200 employees
Learn more about Scorpion Therapeuticsexternal

$100K - $136K/yr

Other

Posted 2 days ago

New

Job description

Senior Scientist, Process Development (CMC)Responsibilities:
  • Design, lead, and optimize iPSC expansion, differentiation, and scale-up processes to improve robustness, reproducibility, and product quality
  • Design and execute development strategies for harvest, downstream processing, formulation, fill-finish, and fresh/cryopreservation for clinical and commercial needs
  • Lead process characterization studies and author technical documentation to support technology transfer, process validation, and GMP readiness
  • Collaborate cross-functionally with Analytical Development and other teams to define critical process attributes and characterize performance
  • Design and conduct studies to develop and optimize biomaterial-based cell delivery approaches, formulation strategies, and clinical in-use hold times
  • Author/review technical reports, process development summaries, protocols, risk assessments, and CMC documentation supporting regulatory submissions
  • Analyze, interpret, and communicate results; provide scientific recommendations
  • Evaluate emerging scientific literature/technologies to identify innovation opportunities
  • Maintain accurate, compliant experimental records; mentor junior scientists/research associates
  • Perform all other duties as assigned
Minimum Requirements:
  • BS with 10 years (or MS with 10 years, or PhD with 5 years) in cell/developmental biology, tissue engineering, biomaterials, biomedical engineering, or related field
  • 5+ years biotech/pharma industry experience
  • Technical expertise in iPS expansion and differentiation
  • Technical expertise in downstream processing, formulation, and stability (fresh and cryo)
  • Experience with lab instrumentation and data software; standard office software
  • Experience supporting FDA/other regulatory submissions via technical reports and CMC documentation
  • Ability to mentor; design and perform complex experiments
  • Excellent written/verbal communication
Preferred Qualifications:
  • PhD or MS in relevant disciplines
  • Experience developing biomaterial-based cell delivery systems (e.g., hydrogels, injectable matrices, scaffolds, ECM-inspired materials)
  • Expertise in automated cell processing equipment (e.g., PBS bioreactor, Rotea, Biowelder, Metaflex, NC200)
  • Experience in tech transfer of cell therapy processes to GMP
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