ZipRecruiter

Log In

1

Cell Therapy Process Development Cmc Director Jobs

AstraZeneca

Process Engineer

Rockville, MD · On-site

This position will report to Director, MS&T, Cell Therapy Development and Operations. Key ... Draft and review CMC sections (Module 3) response to agency question, support health authority and ...

AstraZeneca

Process Engineer

Rockville, MD

This position will report to Director, MS&T, Cell Therapy Development and Operations. Key ... Draft and review CMC sections (Module 3) response to agency question, support health authority and ...

next page

Showing results 1-20

All JobsCell Therapy Process Development Cmc JobsCell Therapy Process Development Cmc Director Jobs

Cell Therapy Process Development Cmc Director information

See salary details

$66.5K

$123K

$170K

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

As of Jun 8, 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 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 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 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 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.
Infographic showing various Cell Therapy Process Development Cmc Director job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $123,000 per year, or $59.1 per hour.
Senior Director, Late Stage Cell Therapy Process Development

Senior Director, Late Stage Cell Therapy Process Development

Sana Biotechnology

Cambridge, MA

$250K - $300K/yr

Other

Posted 18 days ago

Job description

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will report to the Head of Process and Analytical Development and provide strategic, technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. You will build and manage a high performing process development team to develop commercial ready manufacturing processes. You will play a critical role in advancing our pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. Cool Stuff!  This role will require onsite leadership in Cambridge, MA.

What you'll do

  • Partner closely with Research to develop 3D stem cell seed train and differentiation processes, including integration of bioreactors and automated and closed technologies and drug product (DP) process-enabling studies including formulation, fill/finish, and cryopreservation.
  • Lead late stage process development for PSC-derived products, ensuring scalability, robustness, quality and regulatory compliance.
  • Lead process characterization and validation activities, leveraging design of experiments (DoE) and Quality by Design (QbD) approaches and support process performance qualification (PPQ).
  • Establish and execute a comparability strategy for pivotal process changes.
  • Enable technology transfer to CDMOs or internal manufacturing, providing technical input and ensuring successful implementation.
  • Author and review CMC sections of regulatory submissions (e.g., IND, BLA) and support regulatory Q&A and inspections.
  • Collaborate and influence partners across multidisciplinary teams (e.g. Research, Analytical Development, Quality, Regulatory, Manufacturing, Clinical and Supply Chain) to execute on CMC deliverables for pivotal and commercial.
  • Hire, mentor and develop a team of engineers, fostering a culture of trust, curiosity, scientific rigor, collaboration, and continuous improvement across a fast-paced performance driven environment.
  • Contribute to developing the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work.

What we're looking for

  • Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline with a minimum of 10 years experience in cell therapy process development (including >5 years late stage development), with at least 5 years in a leadership role.
  • Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy manufacturing.
  • Knowledge of stem cell biology and 2D/3D stem cell expansion and differentiation, including raw material selection for GMP manufacturing.
  • In depth knowledge and experience with application of engineering principles, DoE and QbD approaches to enable bioreactor scale up and scale down model development.
  • Experience with risk and root cause analysis and tools (e.g. FMEA, Ishikawa).
  • Knowledge of cGMP, and quality and regulatory expectations for commercial cell therapy and/or biologics products.
  • Experience supporting regulatory submissions, Q&A and audits/inspections.
  • Experience supporting tech transfer of a cell therapy process to manufacturing.
  • Strong influencing skills and ability to work in a matrixed, fast paced environment with evolving roles and responsibilities.
  • Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization.

What will separate you from the crowd

  • > 10 years direct experience developing cell therapy processes from pre pivotal to commercial.
  • Experience with optimizing protocols to generate stem cell derived islets
  • Experience with PSC differentiation at >10 L in bioreactors
  • Knowledge of media development including analytical tools to evaluate spent media and regulatory expectations for raw materials.
  • Knowledge of process analytical technology (PAT) and analytical methods for deep characterization of stem cell derived products
  • Strong track record of identifying and implementing novel cell therapy manufacturing technologies into GMP.

What you should know

  • The base pay range for this position at commencement of employment is expected to be between $250,000 and $300,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Apply