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Process Engineer Cell Therapy Jobs in Maryland (NOW HIRING)

Kite Pharma

Cell Therapy Specialist I

Frederick, MD · On-site

$60K - $77K/yr

Cell culture processing experience * Previous experience with cell therapy products is a plus ... The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell ...

Kite Pharma

Cell Therapy Specialist I

Frederick, MD · On-site

$60K - $77K/yr

Cell culture processing experience * Previous experience with cell therapy products is a plus ... The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell ...

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Process Engineer Cell Therapy information

What does a process engineer in cell therapy do?

A Process Engineer in Cell Therapy is responsible for developing, optimizing, and overseeing the manufacturing processes used to produce cell-based therapies. They ensure that processes are efficient, scalable, and compliant with regulatory standards, while maintaining the quality and safety of the final product. Their work often involves collaborating with scientists, quality teams, and production staff to troubleshoot issues and implement improvements. Process Engineers in this field play a crucial role in bringing innovative cell therapies from the laboratory to clinical and commercial production.

What are the key skills and qualifications needed to thrive as a process engineer in cell therapy?

To thrive as a Process Engineer in Cell Therapy, you need a strong background in chemical or biomedical engineering, experience with cell culture processes, and often a relevant degree. Familiarity with GMP regulations, bioprocessing equipment, and quality control systems is typically required, along with experience using tools like bioreactors and analytical software. Excellent problem-solving, communication, and project management skills help you collaborate effectively and drive process improvements. These skills ensure the development and optimization of safe, scalable, and compliant cell therapy manufacturing processes.

What is the difference between Process Engineer Cell Therapy vs Process Engineer Bioprocess?

AspectProcess Engineer Cell TherapyProcess Engineer Bioprocess
CredentialsBachelor's/Master's in Bioengineering, Chemical Engineering, or related fieldsBachelor's/Master's in Bioengineering, Chemical Engineering, or related fields
Work EnvironmentCell therapy manufacturing facilities, GMP labsBiopharmaceutical production plants, GMP facilities
Industry UsageCell therapy companies, biotech firmsBiotech, pharmaceutical manufacturing
Common Search/ComparisonYesYes

Process Engineer Cell Therapy and Process Engineer Bioprocess roles share similar educational backgrounds and work environments, often within GMP manufacturing settings. The main difference lies in their focus: cell therapy engineers specialize in developing and scaling processes for cellular treatments, while bioprocess engineers work on broader biopharmaceutical production. Both roles are essential in biotech industries and often overlap in skills and certifications.

What are some typical challenges faced by process engineers in cell therapy manufacturing, and how are they addressed?

Process Engineers in Cell Therapy often encounter challenges such as scaling up production from clinical to commercial scale while maintaining stringent quality standards and regulatory compliance. Managing variability in biological materials and ensuring consistency across batches is another common hurdle. These challenges are typically addressed through robust process development, close collaboration with quality and manufacturing teams, and implementation of automation and data-driven process controls. Continuous training and adaptation to evolving regulatory guidelines also play a key role in overcoming these obstacles.

What are popular job titles related to Process Engineer Cell Therapy jobs in Maryland?

For Process Engineer Cell Therapy jobs in Maryland, the most frequently searched job titles are:

What job categories do people searching Process Engineer Cell Therapy jobs in Maryland look for?

The top searched job categories for Process Engineer Cell Therapy jobs in Maryland are:

What cities in Maryland are hiring for Process Engineer Cell Therapy jobs?

Cities in Maryland with the most Process Engineer Cell Therapy job openings:

Process Engineer Cell Therapy jobs near you
Infographic showing various Process Engineer Cell Therapy job openings in Maryland as of August 2026, with employment types broken down into 80% Full Time, and 20% Contract. Highlights an 100% In-person job distribution.

Principal Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Oper

AstraZeneca

Gaithersburg, MD • On-site

$122K - $183K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 12 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

22nd of 86 rated pharmaceutical

Job description

AstraZeneca is seeking an experienced principal process engineer for our cell therapy Global Manufacturing Science and Technology (MS&T) team. This position is responsible for the technical oversight of robust, compliant, and cost-effective end-to-end cell therapy manufacturing processes. Activities include leading technology transfer for pivotal clinical manufacturing, process performance monitoring, defining process validation strategy, driving implementation of continuous process improvements, and authoring validation and regulatory deliverables to enable commercialization and lifecycle management across a global network of AstraZeneca's manufacturing sites.
The position reports to the Associate Director, Global MS&T, is based in Gaithersburg, MD, and follows an onsite work model. The role requires up to 15% domestic and international travel.
Responsibilities
Development and Manufacturing Interface
  • Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products
  • Represent Manufacturing Operations on product CMC teams, and ensure high-quality and timely program deliverables (clinical & commercial supply, site approvals)
  • Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites
  • Develop proactive process analysis and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites

Lifecycle Management
  • Provide technical oversight across cell therapy manufacturing lifecycle - from pivotal manufacturing technology transfer, process validation, commercialization, and post-approval
  • Identify and implement process improvements that increase process robustness, cost of goods, plant throughput, and supply continuity
  • Manage post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks
  • Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams

Regulatory & Quality Support
  • Lead global Change Controls and ensure timely implementation and compliance
  • Author CMC sections of regulatory submissions - Pivotal INDa, BLA, MAA, and supplements -with high efficiency and optimal content
  • Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations
  • Develop and defend sound scientific justifications for the integrated control strategy and lifecycle changes

Cross-Functional Partnerships
You will work in close partnership with:
  • Late-Stage Process Development - Ensure process definition, improvements, and process characterization reflect lifecycle strategy
  • Site MS&T - partner to ensure timely implementation of process changes and improvements at the sites
  • Quality - ensure process compliance and product quality standards
  • CMC Regulatory - align on submission strategy and regulatory positioning
  • Supply Chain - inform long-range supply planning and risk mitigation
  • CMC Leadership - provide MSAT input for late-stage development and commercial readiness

Qualifications
Education
  • B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.

Experience
  • Ph.D. with 4+ years; OR M.S. with 8+ years, OR B.S. with 10+ years of relevant cell therapy/biologics/vaccines industry experience in technical development, MS&T, or CMO management areas.
  • Technical and hands-on expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in viral vectors, vaccines, or biologics will be considered.
  • Extensive background in GMP manufacturing operations and technology transfer. Experience in process validation and CPV.
  • Experience in authoring and defending CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections.
  • High standards of quality, accountability, and urgency - with the resilience to thrive in a fast-paced cell & gene therapy field.

The annual base pay for this position ranges from $122,312.80 - $183,469.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
09-Aug-2026
Closing Date
27-Aug-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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