Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

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 )

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

CrossFunctional 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

Minimum 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 handson industry experience OR B.S. with 8 years of handson 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 problemsolving skills.

Soft skills

Excellent crossfunctional 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 latestage clinical manufacturing support of cell therapy products

Experience with process validation and commercial readiness of cell therapy products

Work Environment

On-site in Tarzana CA

Ability to travel 15% to other manufacturing facilities

On-call rotation during engineering/PPQ/critical campaigns