MSAT Analytics Scientist II: Cellular Therapy Transfer Lead

Miltenyi Biotec, Inc.; San Jose (CA); On-site; USD 120,000 - 142,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

401(k) plan

Job summary

Miltenyi Biotec, Inc. in San Jose, CA is seeking a leader to drive analytical transfer for testing cellular therapy products into Process Sciences. The role may act as process owner and lead medium-scope continuous improvement projects aligned with department goals.

Key duties include liaising between PS and QC, supporting transfers into/out of QC, contributing to stability programs, and authoring GMP documents, protocols, and reports, with emphasis on risk assessments and CAPA when issues arise.

Qualifications

• Bachelor's or advanced degree in a biological/biomedical discipline.
• 5-8 years progressive experience in clinical processing analytical testing or cell culture operations.

Responsibilities

• Liaison between Process Sciences and QC for analytics.
• Support analytical transfer into PS and into/out of QC.
• Support stability program activities.
• Participate in R&D activities.
• Author/review GMP documentation, protocols and reports.
• Serve as process owner and drive medium-scope CI projects.
• Troubleshoot analytical issues; investigate OOS and implement CAPA.
• Lead risk assessments and root cause analyses.

Skills

Analytical transfer

Process owner

CAPA & root cause

Technical writing

Risk assessments

Liaison with PS and QC

Education

Biological/biomedical degree

Tools

Flow cytometry

ELISA

QPCR

Job description

Miltenyi Biotec, Inc. in San Jose, CA is seeking a leader to drive analytical transfer for testing cellular therapy products into Process Sciences. The role may act as process owner and lead medium-scope continuous improvement projects aligned with department goals.

Key duties include liaising between PS and QC, supporting transfers into/out of QC, contributing to stability programs, and authoring GMP documents, protocols, and reports, with emphasis on risk assessments and CAPA when issues arise.