Senior Cell Therapy Process Engineer On-the-Floor Leader

AstraZeneca GmbH; Los Angeles (CA); On-site; USD 103,000 - 155,000; Full time

Job summary

AstraZeneca GmbH is seeking a senior cell therapy manufacturing professional to support on-the-floor manufacturing, drive deviations and CAPAs, and lead technology transfer initiatives. The role includes data analysis, batch record documentation, and cross-functional collaboration to ensure GMP-compliant cell therapy production.

The ideal candidate has hands-on experience in cell therapy unit operations and process validation, with strong troubleshooting and regulatory writing skills.

Qualifications

• PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR MS with 5+ years of hands-on industry experience, OR B.S. with 8+ years of hands-on industry experience.
• GMP experience including batch record execution/review, deviations, and investigations.
• Proficiency with statistical analysis (univariate, multivariate; control charts)
• Strong technical writing and clear verbal communication
• Strong data analysis and problem-solving skills

Responsibilities

• Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns.
• Represent site MS&T at site operational tier meetings and drive site activities.
• Perform data trending, analysis, and control-chart-based actions with cross-functional alignment.
• Lead or co-lead investigations for deviations; develop and implement CAPAs with data.
• Collaborate with automation/digital teams to improve electronic batch records.
• Draft and revise batch records, SOPs, and regulatory documents in line with cGMP/ATMP requirements.

Skills

Cell therapy operations

GMP compliance

Statistical analysis

Technical writing

Data analysis

Education

PhD in Chemical/Biochemical Engineering or related field

MS in engineering or related field

BS with extensive industry experience

Job description

AstraZeneca GmbH is seeking a senior cell therapy manufacturing professional to support on-the-floor manufacturing, drive deviations and CAPAs, and lead technology transfer initiatives. The role includes data analysis, batch record documentation, and cross-functional collaboration to ensure GMP-compliant cell therapy production.

The ideal candidate has hands-on experience in cell therapy unit operations and process validation, with strong troubleshooting and regulatory writing skills.