Jobs in the United States

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Databricks Engineer
Randstad USA
Remote, United States
- $48.66 to $58.66 USD / hour
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Added 2 mins ago
Software Engineer
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Senior Associate, RF/Wireless Engineer
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Lead, Power Supply Electrical Engineer
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Carlsbad, CA · San Diego, CA · Salt Lake City, UT
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Mountain View, CA
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DevSecOps Engineer (Mid)
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Sr. Manufacturing Engineer
Schenck USA Corp
Hudson, MA
- $100,000 to $110,000 USD / year
Test Devices by Schenck is seeking to hire a Sr. Manufacturing Engineer!
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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
To qualify for the role you must have
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Senior Acquisition Engineer
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Acquisition Lifecycle Engineer
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Acquisition Capability Area Lead
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Mechanical Engineer - Advanced Robotics Intern
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MA
Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog,…
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Associate Manufacturing Engineer (RF, Microwave)
AD Federal
MA
At ADFED LLC, we design and manufacture advanced RF, microwave, and electronic solutions that support critical aerospace and defense missions around the world. We are seeking a…
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Senior Engineer, Security Solutions
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Des Moines, IA
The Senior Engineer, Security Solutions leads the technical design and integration of complex security systems automation and controls solutions, including access control, video…
Added 13 mins ago
Software Engineer
Altamira Technologies Corp.
Englewood, CO · Warrenton, VA
Position Description: We are seeking a Software Engineer who possesses a mix of talent areas related to full-stack development. Examples of technologies we are currently using to support…
Added 14 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 18 mins ago
Associate FPGA Engineer (TVI)
Thales Defense & Security, Inc.
AURORA, IL
We are seeking an Associate FGPA Engineer to work in our Aurora, IL office. You will be part of small product development teams working with extremely talented, motivated people who take…
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Information Assurance Specialist
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United States
Oversees the efforts of the contractor security staff to design, develop, engineer and implement solutions to security requirements.
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Electrical Engineer 1 (Entry Level) - Energy & Industrial
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This position is based on a hybrid work schedule and will require in-office work 3 days per week
Added 19 mins ago
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Project Manager - Water/Wastewater
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- $105,000 to $150,000 USD / year
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Added 20 mins ago
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Lead Electrical Engineer - 1116
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Broomfield, CO
- $164,000 to $185,000 USD / year
We are seeking a Lead Electrical Engineer in our Broomfield, CO location. In this role, you will lead a team to develop and deliver large-scale electrical systems that control our…
Added 23 mins ago
Java Engineer
Infosys
United States
The Infosys Financial Services unit is a global leader in driving digital transformation for financial institutions. We specialize in leveraging advanced technologies such as AI, cloud, and…
Added 23 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 25 mins ago
Principal - Software Engineer
Ally Bank
Charlotte, NC
Hybrid roles are generally expected to be in the office a certain number of days per week as indicated by your manager

AstraZeneca Pharmaceuticals LP Company

Senior Process Engineer, Cell Therapy Process Development

Gaithersburg, MD, 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: Nov 20, 2026
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