Jobs in the United States

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Added 1 min ago
Acquisition Capability Area Lead
The Aerospace Corporation
Chantilly, VA · Huntsville, AL
The Acquisition Planning and Decision Analytics (APDA) Department is seeking a Senior Acquisition Engineer to join a diverse, innovative, and highly productive team of acquisition and…
Added 1 min ago
Manager, Supply Planner
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Champion the simplification, standardization, automation, and effective use of planning systems, ERP capabilities, master data, advanced analytics, and AI
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Head of FP&A (Senior Director)
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San Francisco, CA
- $220,000 to $275,000 USD / year
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Added 3 mins ago
GTM Manager
Accenture LLP Company
United States
…multi-channel digital experiences that drive awareness, engagement, and pipeline growth. You bring a strong blend of content creation, performance marketing, and storytelling - crafting…
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GTM Associate Manager
Accenture LLP Company
United States
…serves as the growth engine of the Americas business. We set and drive the strategic priorities of the business, enabling growth through data-driven, insight-led marketing, enablement, and…
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Field Service Engineer 3
Onto Innovation Inc-US
Remote, United States
…micron-level die-interconnects; macro defect inspection of wafers and packages; metal interconnect composition; factory analytics; and lithography for advanced semiconductor packaging. Our…
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Field Service Engineer 3
Onto Innovation Inc-US
United States
…micron-level die-interconnects; macro defect inspection of wafers and packages; metal interconnect composition; factory analytics; and lithography for advanced semiconductor packaging. Our…
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Manager, Applications Science
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United States
…micron-level die-interconnects; macro defect inspection of wafers and packages; metal interconnect composition; factory analytics; and lithography for advanced semiconductor packaging. Our…
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Director of Product Marketing
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United States
…micron-level die-interconnects; macro defect inspection of wafers and packages; metal interconnect composition; factory analytics; and lithography for advanced semiconductor packaging. Our…
Added 4 mins ago
Software Engineer
Altamira Technologies Corp.
Englewood, CO · Warrenton, VA
…JavaScript/Typescript, Python, Angular, ELK stack, Redis, Web Services (REST), Data Analytics, NoSQL and SQL databases, Digital Signal…
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Director, Peraton[x] Administration and Enablement
Peraton
Remote, United States
Peraton is seeking a Director to lead the administration and user enablement of Peraton[x], our enterprise generative AI and agentic analytics platform. This leader is accountable for how…
Added 5 mins ago
AP
Senior Process Engineer, Cell Therapy Process Development
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $96,000 to $144,000 USD / year
Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.
Added 5 mins ago
Global Insights Director
AstraZeneca Pharmaceuticals LP Company
Wilmington, DE
The Director is accountable for setting the insights, analytics and AI-enabled evidence agenda for a key brand. As a member of the Brand Leadership Team, this role influences senior…
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Production Supervisor-Nights
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Must have strong prioritization skills
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Production Supervisor
Vertiv
Franklin Furnace, OH
Must have strong prioritization skills
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Senior Financial Analyst
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Manager, Quality & Compliance
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Mettawa, IL
- $109,500 to $208,500 USD / year
This role requires the candidate to be physically located in Lake County, Illinois and adhere to 3-day in office ways of working · The individual must possess sound judgment in evaluating and establishing compliance strategic plans as well as in day-to-day situations
Added 5 mins ago
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Director, Internal Communications
Ipsen Biopharmaceuticals Inc.
United States
- $177,000 to $259,600 USD / year
Leverage employee feedback, engagement data, and communication anal
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Business Analyst
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Murrysville, PA
This role serves as the bridge between business needs and technology delivery. The position manages multiple priorities, gathers requirements, performs process and system analysis, supports…
Added 6 mins ago
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Sr. Business Operations Analyst
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- $83,920 to $104,900 USD / year
The position oversees critical business functions including gas and power settlement reporting and reconciliation, budget support, and executive reporting while driving continuous…
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Head of Custody Operations and NAM Lead for Investor Services Operations
Citi
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Enforce strict client asset segregation, cross-border custody tax governance, and global regulatory compliance
Added 6 mins ago
Senior Data Scientist - BESS
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Houston, TX · Boston, MA · Burlington, VT
As a Senior Data Scientist – BESS, you will lead the design and development of scientifically rigorous analytics solutions leveraging Power Factors' extensive operational data, covering…
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Head of Software Architecture
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Added 7 mins ago
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Patent Attorney - Software, AI/ML & Advanced Computing
MNF Global
Atlanta, GA
- $270,000 to $320,000 USD / year
AI/ML, predictive modeling and data analytics.
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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