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Added 2 mins ago
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Project Engineer
Actalent
Wildwood, FL
- $31 to $43 USD / hour
Job Title: Project Engineer / Project CoordinatorJob DescriptionThis entry-level Project Engineer / Project Coordinator role supports the successful planning, coordination, and execution of…
Added 3 mins ago
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Senior Mechanical Project Engineer
SpecSys
New Ulm, MN
- $90,000 to $105,000 USD / year
The Senior Project Mechanical Engineer completes mechanical design work for mobile equipment that includes structural, fluid power and powertrain systems, manages complex design and…
Added 3 mins ago
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Senior Mechanical Project Engineer
SpecSys
Minneapolis, MN
- $90,000 to $105,000 USD / year
The Senior Project Mechanical Engineer completes mechanical design work for mobile equipment that includes structural, fluid power and powertrain systems, manages complex design and…
Added 3 mins ago
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Senior Mechanical Project Engineer
SpecSys
Granite Falls, MN
- $90,000 to $105,000 USD / year
The Senior Project Mechanical Engineer completes mechanical design work for mobile equipment that includes structural, fluid power and powertrain systems, manages complex design and…
Added 3 mins ago
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Senior Mechanical Project Engineer
SpecSys
Montevideo, MN
- $90,000 to $105,000 USD / year
The Senior Project Mechanical Engineer completes mechanical design work for mobile equipment that includes structural, fluid power and powertrain systems, manages complex design and…
Added 5 mins ago
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Senior Process Engineer, Cell Therapy Process Development
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $96,000 to $144,000 USD / year
We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in…
Added 7 mins ago
Head of Software Architecture
Power Factors
Houston, TX · Boston, MA · Burlington, VT
…product complexity without sacrificing reliability, security, or development…
Added 8 mins ago
Sr. Specialist, Systems Engineer (Environmental Qualification)
Acron Aviation
Phoenix, AZ · Grand Rapids, MI
Acron Aviation is seeking a Senior Specialist, Systems Engineer for our Environmental Qualifications to provide technical leadership for the planning, coordination, execution, and closure…
Added 8 mins ago
Senior Reliability Engineer
AVE Medtronic Vascular Inc
Mounds View, MN
This position will be based at our Mounds View, MN facility which requires a minimum of 4 days per week on-site for in-person collaboration
Added 9 mins ago
Senior Controls and Automation Engineer
Patterson-UTI Drilling Company LLC
Houston, TX
The Senior Controls and Automation Engineer will be responsible for the conception, design, development, implementation, and maintenance of drilling rig control system software and…
Added 11 mins ago
Engineer Lead Senior
The Elevance Health Companies, Inc.
United States
The Engineer Lead Senior is responsible for leading the end to end application system development and maintenance on large complex enterprise wide technology platforms.
Added 11 mins ago
Senior Software Engineer, Agent Oversight
Scale AI
San Francisco, CA · NY
…decisions. As the leading AI data foundry, we provide the high-quality data and full-stack technologies that power the world’s most advanced models - fueling breakthroughs in generative AI,…
Added 12 mins ago
Engineer III or Senior Engineer (Electrical)
Duke Energy
Seneca, SC
Senior Nuclear Engineer is the career/senior level of the Engineering classification hierarchy. Employees at this level manage work in engineering areas of electrical systems and components…
Added 12 mins ago
Network Engineer - Principal
Amentum
Warrenton, VA
Must have active Top-Secret clearance with SCI or the ability to acquire Top Secret/SCI
Added 12 mins ago
Engineer 1
M. C. Dean
Rock Hill, SC
The Engineer provides system programming and management support for large scale networking infrastructures. The responsibilities include the administration and maintenance of high…
Added 12 mins ago
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Technology Engagement Manager
Kiewit
Lone Tree, CO
- $163,000 to $170,000 USD / year
…resilient infrastructure that meets the safety, schedule, and quality demands of the public agencies and clients we serve. Beyond Transportation, this role may also provide opportunities to…
Added 12 mins ago
Senior Electrical Engineering Leader - Power Infrastructure
GE Vernova
Greenville, SC
…unique industrial power systems in North America, supporting the development, validation, and testing of advanced power generation…
Added 14 mins ago
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Senior Process Engineer, Cell Therapy Process Development
AstraZeneca
Gaithersburg, MD · Gaithersburg
- $96,000 to $144,000 USD / year
We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in…
Added 15 mins ago
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AI Solutions Engineer, GTM
OpenGov
Chicago, IL
- $150,000 to $165,000 USD / year
OpenGov is seeking an AI Solutions Engineer to serve as a dedicated practitioner within the Applied AI team, focused on Sales/GTM use cases across the revenue organization - SDR outbound,…
Added 15 mins ago
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Forward Deployer Engineer (Revenue)
OpenGov
Chicago, IL
- $150,000 to $165,000 USD / year
OpenGov is seeking a Forward Deployed Engineer (Revenue) to serve as a dedicated practitioner within the Applied AI team, focused on Sales/GTM use cases across the revenue organization -…
Added 20 mins ago
Senior Scientist/Engineer
Braun Intertec Corporation
Fort Worth, TX
As a senior multi-media environmental permitting and compliance professional in our Permitting and Compliance practice group, you will lead projects, strengthen client relationships, mentor…
Added 21 mins ago
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Bridge Design Branch Chief
Department of Transportation
CA
- $11,437 to $14,315 USD / month
The Division of Engineering Services, Office of Bridge Design, Office of Bridge Design North, is recruiting for a Senior Bridge Engineer (Supervisor) position, located in Sacramento.
Added 24 mins ago
Project Manager - Mission Critical (New York, Wallingford, Morristown, Newton)
Burns & McDonnell
Manhattan, NY · Wallingford, CT · Morristown, NJ · Newton, MA · Troy, NY
Specific areas of responsibility include the following, with other duties as assigned by senior management:
Added 26 mins ago
Senior Software Engineer, Finance Technology (Forward Deployed)
Vista Equity Partners Management
Austin, TX
Vista Equity Partners is seeking a Senior Software Engineer to serve as the forward deployed engineer for thefirm's Finance organization. This individual contributor role, at the Associate…
Added 26 mins ago
Staff Software Engineer, Enterprise AI & Automation
Vista Equity Partners Management
Austin, TX
Vista Equity Partners is seeking a Staff Software Engineer to join Enterprise AI & Automation, a small,senior team building the production AI applications and shared platform that Vista's…

AstraZeneca

Senior Process Engineer, Cell Therapy Process Development

Gaithersburg, MD, United States
Gaithersburg, United States

$96,000 to $144,000 USD / year

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Job details

Pay: $96,000 to $144,000 USD / year
Apply by: May 11, 2027
Posting language: English
Posted: Nov 12, 2026

Original job description

Position Summary We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to different manufacturing sites.

This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment. The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.

Key Responsibilities

Process development and characterization

Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
Drive implementation of closed-system operations and automation strategies to support scalability and compliance.
Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines.
Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums.
Support development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters.
Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.

PPQ, Tech Transfer & Manufacturing Readiness

Contribute to PPQ planning, readiness, execution, and documentation for cell therapy processes.
Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record.
Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.

Regulatory Support

Contribute to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.

Cross‑Functional Collaboration

Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.
Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.
Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes.

Required Qualifications

Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands‑on industry experience.
Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation).
Demonstrated experience with GMP operations and late‑stage / commercial readiness.
Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels
Experience with late‑stage development, process characterization, and PPQ principles for cell therapy processes.
Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
Experience working in GMP environments, including batch record execution or review, deviations, and investigations.
Strong technical writing, data analysis, and problem‑solving skills.

Preferred Qualifications

Experience with viral vector handling (Lentivirus, AAV) in manufacturing processes.
Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors).
Experience implementing closed, automated, or high‑throughput systems.
Experience designing and executing DOE and multivariate data analysis for cell therapy processes.
Experience with JMP or similar statistical analysis tools.
Experience contributing to BLA/MAA submissions or regulatory interactions.
Knowledge of control strategy development and risk assessment tools (e.g., FMEA).
Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.

Key Competencies

Strong experimental design and execution skills.
Excellent cross‑functional communication and collaboration.
Ability to operate effectively in fast‑paced, late‑stage development environments.
Scientific curiosity, ownership mindset, and willingness to support manufacturing operations.

The annual base pay for this position ranges from $96K to $144K. Our positions offer eligibility for multiple 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. # Cell Therapy

Date Posted 12-Nov-2026 Closing Date 19-Nov-2026Our 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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Jobs in the United States