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Offensive Security Automation Engineer
EY
Detroit, MI · Dallas, TX · Houston, TX · Cleveland, OH · Fort Worth, TX · New Orleans, LA · Atlanta, GA · Philadelphia, PA · Chicago, IL · Minneapolis, MN · Pittsburgh, PA · Grand Rapids, MI · Alpharetta, GA
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Principal AI-Native Software Engineer
AT&T Services, Inc.
Remote, United States
- $155,400 to $261,100 USD / year
This is a full-time onsite role based in the location(s) posted and is performed from the designated work location five days per week
Added 1 min ago
Acquisition Capability Area Lead
The Aerospace Corporation
Chantilly, VA · Huntsville, AL
…engaged across all aspects of space - delivering innovative solutions that span satellite, launch, ground, and cyber systems for defense, civil and commercial customers. When you join our…
Added 1 min ago
Mechanical Engineer - Advanced Robotics Intern
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MA
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Associate Manufacturing Engineer (RF, Microwave)
AD Federal
MA
…combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and…
Added 2 mins ago
Senior Platform Engineer – TS/SCI
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Chantilly, VA
We are seeking an experienced Senior Platform Engineer specializing in enterprise Linux infrastructure, Kubernetes, container orchestration, and platform automation.
Added 2 mins ago
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Senior Software Engineer
Obviant
Arlington, VA
- $160,000 to $210,000 USD / year
You'll be architecting and scaling the core backend systems, APIs, and data infrastructure powering the next generation of defense intelligence tools. We move fast, ship often, and solve…
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Senior Software Engineer
Obviant
Tampa, FL
- $150,000 to $200,000 USD / year
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Added 3 mins ago
Field Service Engineer 3
Onto Innovation Inc-Taiwan
Remote, United States
We are seeking a highly skilled and customer-focused Field Service Engineer 3 (FSE 3) bases in Phoenix, AZ, to provide advanced on-site technical support, installation, maintenance, and…
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City Engineer
City of Hutto
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…manage workflow while performing functions as the City’s Chief Engineer, and all duties as assigned by the City…
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Test Automation Software Engineer
Altamira Technologies Corp.
Warrenton, VA · Fort Eisenhower, GA · Centennial, CO
Altamira Technologies has a long and successful history providing innovative solutions throughout the U.S. National Security community. Headquartered in McLean, Virginia, Altamira serves…
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Software Integration Engineer
Altamira Technologies Corp.
Warrenton, VA · Fort Eisenhower, GA · Centennial, CO
Altamira Technologies has a long and successful history providing innovative solutions throughout the U.S. National Security community. Headquartered in McLean, Virginia, Altamira serves…
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Software Engineer
Altamira Technologies Corp.
Englewood, CO · Warrenton, VA
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Senior Network Engineer
Altamira Technologies Corp.
McLean, VA · Chantilly, VA
Altamira Technologies has a long and successful history providing innovative solutions throughout the U.S. National Security community. Headquartered in McLean, Virginia, Altamira serves…
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Senior Linux System Administrator
Altamira Technologies Corp.
McLean, VA · Chantilly, VA
Altamira Technologies has a long and successful history providing innovative solutions throughout the U.S. National Security community. Headquartered in McLean, Virginia, Altamira serves…
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Interface Engineer
Altamira Technologies Corp.
Warrenton, VA · Fort Eisenhower, GA · Centennial, CO
Altamira Technologies has a long and successful history providing innovative solutions throughout the U.S. National Security community. Headquartered in McLean, Virginia, Altamira serves…
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Software Engineer
Dezign Concepts LLC
Chantilly, VA
- $250,000 USD / year
Build scalable AI/ML solutions, data pipelines, and web applications that support intelligence analysis.
Added 5 mins ago
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Network Engineer
Rahr Malting Co
Shakopee, MN
- $100,000 to $120,000 USD / year
RahrBSG is looking for a Network Engineer in Shakopee, Minnesota. The Network Engineer designs, deploys, maintains, and supports secure, reliable network infrastructure, with a primary…
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Platform Solutions Engineer
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San Francisco, CA
- $180,000 to $220,000 USD / year
- Design technical solutions for clients who connect the software to their cloud and on-premises systems.
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AP
Senior Process Engineer, Cell Therapy Process Development
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $96,000 to $144,000 USD / year
Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
Added 5 mins ago
Quality Engineer - Core
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This Quality Engineer is in Whitehall, Michigan at our Core Facility. The position will resolve manufacturing and shipment issues related to customer specifications. Drive root cause and…
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Principal Engineer, Electrical & Electronics Engineering
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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