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Added 13 hours ago
Division Director, Behavioral Health Care Services
County of Alameda
Oakland, CA
The equivalent of five years of full-time, post-graduate professional management and supervisory experience in directing a large public or private health care program or organization, which…
Added 16 hours ago
Associate Project Manager
The University of Texas at Austin
United States
…required and performing duties. Required to carry University cell…
Added 16 hours ago
D
Supply Chain Operator in Devens, MA
Devens
Devens, MA
- $30.81 to $37.33 USD / hour
The Supply Chain Operator role is responsible for providing on the floor support and participate in materials management activities across the Cell Therapy Facility, specifically focusing…
Added 17 hours ago
AS
Nightshift Cell Operator 2nd Shifts Available
Aventure Staffing
Spirit Lake, IA
- $20 to $23 USD / hour
Aventure Staffing is seeking Cell Operators to work for a well established, climate controlled manufacturing company in Spirit Lake, IA. Training provided
Added 18 hours ago
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CNC Machinist
Aerotek
La Porte, IN
- $24 to $28 USD / hour
Job Title: CNC Lathe Setup Operator / MachinistJob DescriptionThis role is a hands-on CNC lathe setup operator position in a high-volume manufacturing environment, focused on setting up,…
Added 18 hours ago
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Machine Operator
Aerotek
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Maintain Operator Certification to be able to accept/reject parts.
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Added 1 day ago
Senior Manufacturing Test Engineering, Propulsion
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Added 1 day ago
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Machine Shop Operator
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Added 1 day ago
Manufacturing Test Engineering, Propulsion
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Added 1 day ago
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AstraZeneca

Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

Rockville, MD, United States
Rockville, United States

The annual base pay (or hourly rate of compensation) for this position ranges from $94, 256.80 - $141, 385.20.

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Job details

Pay: The annual base pay (or hourly rate of compensation) for this position ranges from $94, 256.80 - $141, 385.20.
Apply by: Apr 26, 2027
Posting language: English
Posted: Oct 28, 2026

Original job description

Location: AstraZeneca, Rockville, MD Travel: Up to 15% domestic and international travel required

Position Summary We are seeking an experienced Senior Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team at AstraZeneca’s Rockville, MD cell therapy manufacturing facility.

This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products. Responsibilities include leading on-the-floor / hands-on technical support, developing technical instructions, procedures, and operator training content, performing data analysis and process performance trending, leading complex deviation investigations, driving implementation of CAPAs and continuous improvement through change controls, and contributing to validation and regulatory deliverables. These responsibilities will be exercised through the scope of supporting technology transfers, clinical manufacturing, site readiness, process validation/PPQ, commercial manufacture readiness, and product lifecycle management activities.

The ideal candidate brings hands-on experience with cell therapy unit operations through previous experience in process development and/or manufacturing, as well as expertise in technology transfer. Experience with process validation and commercialization activities is desired. This position will report to Director, MS&T, Cell Therapy Development and Operations.

Key Responsibilities

Site manufacturing support

Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns (including occasional off-shift support where required)
Operations Support: Represent Site MS&T function at site operational tier meetings, providing collaborative inputs that drive site activities
Data trending and analysis: Maintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and cross-functional alignment.
Process performance monitoring: Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
Deviation/CAPA Support: Lead or co-lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data.
Continuous improvements: Identify, justify, and implement continuous improvements by shepherding changes through cross‑functional change controls with appropriate risk assessments and comparability.
Raw materials: Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and contribute to second-source strategies
Automation: Partner with automation/digital manufacturing teams to implement electronic batch record improvements
Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+).
Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; contribute to lessons-learned, playbooks, and best practices across sites.
Regulatory Contributions: Draft and review CMC sections (Module 3) response to agency question, support health authority and internal audits/inspections.

Technology Transfer & Process Validation

Draft and review risk assessments and comparability study design
Contribute to technology transfer packages (process descriptions, URS inputs, BOMs, risk assessments), implement process changes, coordinate execution of engineering runs and comparability/bridging studies, author technical reports
Translate process characterization outputs from development into manufacturing controls, and draft sections of PPQ protocols/reports
Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).

Cross‑Functional Collaboration

Position serves as primary interface between site Manufacturing, site Quality, site Supply Chain, and global functions of Process Development and CMC regulatory
Support lifecycle management for cell therapy processes, including continuous improvement initiatives and post-approval changes

Required Qualifications Education PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 5+ years of hands‑on industry experience, OR B.S. with 8+ years of hands‑on industry experience.

Technical Skills

Strong technical and hands-on expertise in key cell therapy unit operations and common cell therapy processing equipment
Demonstrated experience working in GMP environments, including batch record execution or review, deviations, and investigations.
Proficiency with statistical analysis (including univariate, multi-variate analysis, control charts)
Demonstrated ability in accurate and thorough technical writing, paired with clear and concise verbal communication
Strong data analysis, and problem‑solving skills.

Soft skills

Excellent cross‑functional communication and collaboration.
Ability to translate complex data into clear decisions and regulatory-ready narratives.
Excellent problem solving, cross-functional leadership, and communication under time-sensitive conditions.

Preferred Qualifications

Experience with late‑stage clinical manufacturing support of cell therapy products
Experience with process validation and commercial readiness of cell therapy products

Work Environment

On-site in Rockville, MD
Ability to travel ~15% to other manufacturing facilities
On-call rotation during engineering/PPQ/critical campaigns

The annual base pay (or hourly rate of compensation) for this position ranges from $94, 256.80 - $141, 385.20. 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 28-Oct-2026 Closing Date 26-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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More about this job

Skills

Technical support
Perform data analysis
Process improvement
Documentation
Manufacturing processes
Root cause analysis
Good manufacturing practices
Regulatory compliance
Internal auditing
Inspection
Collaboration
Supply chain management
Chemical engineering
Biotechnology
Statistics
Technical writing
Communication skills
Data analysis
Problem solving
Leadership
Sales

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