Senior Process Engineer, Manufacturing, Science & Technology, Cell Therapy

Senior Process Engineer Manufacturing Sciences & Technology Cell Therapy:

Location: AstraZeneca Rockville MD

Travel: Up to 15%domesticand international travel

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 AstraZenecas 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 giving to validation and regulatory work. These responsibilities will be exercised through the scope of supporting technology transfers clinical manufacturing site readiness process validation/PPQ commercial manufacture readiness andproductlifecycle management activities.

The ideal candidate brings hands-on experience with cell therapy unit operations throughpreviousexperience in process development and/or manufacturing as well asexpertisein technology transfer. Experience with process validation and commercialization activities is desired. This position will report to Director MS&T Cell TherapyDevelopmentand 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)

Operations Support: Represent Site MS&T function at site operational tier meetings providing collaborative inputs that drive site activities

Data trending and analysis:Maintainmanufacturing data tracking system and control charts perform trend analysesidentifysignals and drivetimelysignal-to-action with clear documentation and multi-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 analysisdevelopand implement CAPAs withappropriate data.

Continuous improvements:Identify justify and implement continuous improvements by shepherding changes through multi-functional change controls withappropriate riskassessments 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 supply 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 alignment to cGMP/ATMP requirements and data integrity principles (ALCOA).

Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; chip in to lessons-learned playbooks and guidelines across sites.

Regulatory Contributions: Draft and review CMC sections (Module 3) response to agency question support healthauthorityand internal audits/inspections.

Technology Transfer & Process Validation

Draft and review risk assessments and comparability study design

Chip in 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 onthefloor technical support during scaleup engineering runs PPQ batches and commercial manufacturing campaigns (including offshift support when).

Multi-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

Minimum Education and experience:

B.S. with 8 years ofhandsonindustry experience. M.S. with 5 years ofhandsonindustry experience PhD in Chemical Engineering Biochemical Engineering Biotechnology or related field with 1 years of industry experience

Technical Skills

Strong technical and hands-onexpertisein key cell therapy unit operations and common cell therapy processing equipment

Demonstratedexperience working in GMP environments including batch record execution or review deviations and investigations.

Proficiencywith statisticalanalysis(including univariate multi-variate analysis control charts)

Provenability inaccurateand thorough technical writing paired with clear and concise verbal communication

Strong data analysis and problemsolving skills.

Soft skills

Excellent multi-functional communication and collaboration.

Ability to translate complex data into clear decisions and regulatory-ready narratives.

Excellent problem solving multi-functional leadership and communication under time-sensitive conditions.

Preferred Qualifications

Experience with latestage 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 $103286.40to $154929.60.Our positions offer eligibility for various incentivesan 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 coveragein accordance withthe terms of the applicable plans.