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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 · 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 ...

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Cell Therapy Process Development Cmc Director information

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$66.5K

$123K

$170K

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

As of Jun 9, 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 CMC Project Manager - Cell Therapy / Biopharma

SOKOL GxP Services

Seattle, WA • On-site

$61.10 - $74.55/hr

Contractor

Medical, Retirement

Posted yesterday

Job description

SOKOL GxP Services is looking for a Senior CMC Project Manager to lead technical drug development programs within a GMP-regulated environment.

This role will focus on the planning, execution, and delivery of CMC initiatives supporting cell therapy or biologics programs across development and manufacturing.

The Senior Project Manager will operate within a cross-functional environment, driving alignment across Process Development, Manufacturing, MSAT, Quality, and Regulatory teams. This role requires strong ownership of timelines, risks, and deliverables, ensuring programs are executed efficiently and in alignment with overall development strategy.

This is a highly visible role supporting complex, technical programs, requiring both project management expertise and a solid understanding of CMC drug development.

Key Responsibilities
  • Lead end-to-end project management of CMC drug development programs
  • Develop and maintain project plans, timelines, and deliverables
  • Coordinate cross-functional teams including Process Development, MSAT, Manufacturing, QA, and Regulatory
  • Manage project risks, budgets, and resources
  • Drive execution of programs aligned with technical and business objectives
  • Track and communicate project status to stakeholders and leadership
  • Support tech transfer, process development, and manufacturing readiness activities
  • Ensure alignment with GMP requirements and internal standards
  • Facilitate team meetings and ensure accountability across workstreams

Requirements

Required Experience
  • 5+ years of experience in biopharma / life sciences project management
  • Strong background in CMC drug development
  • Experience working in a GMP-regulated environment
  • Proven ability to manage cross-functional teams in a matrix organization
  • Hands-on experience with project planning tools (MS Project or similar)
  • Strong understanding of drug development lifecycle (IND to commercialization
  • Experience with cell therapy or biologics
  • Exposure to tech transfer, MSAT, or manufacturing operations
  • PMP certification

Benefits

Competitive hourly rate: $61.10/hr to $74.55/hr. (W-2 only, no C2C)

Hybrid position - 50% onsite required

Working Hours: Monday - Friday, regular business hours

10-month contract with possible extension

Health insurance, holiday pay, 401(k) program, and other benefits