GMP QC Analytical Lead & Method Transfer Expert

GeneFab; Alameda (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

GeneFab seeks an experienced QC Analytical Analyst to support GMP QC testing, method transfers, qualification, troubleshooting, and investigations in a fast-paced cell therapy environment.

The role partners with Analytical Development, QC Operations, and manufacturing teams to ensure compliance, data integrity, and timely release of products. Strong data analysis and problem-solving are essential, as are attention to detail and teamwork.

Qualifications

• BS in biology or related field with GMP/QC exposure.
• Minimum of 5+ years of GMP/QC Laboratory experience.
• Strong analytical and problem‑solving skills.

Responsibilities

• Provide SME support to Analytical Development and QC Analytical Operations as needed.
• Develop, implement, and update all Quality Control SOPs, testing records and other documentation needed for cGMP compliance.
• Perform QC testing on in-process and final product samples to support release and stability testing.
• Lead and perform technical root-cause investigations for aberrant results and deviations relating to analytical methods.
• Lead and train junior employees to ensure testing procedures and practices comply with all applicable regulations and procedures.
• Plan, lead, and execute analytical method transfers, qualifications, and validations.
• Draft, Review, and Approve Method Transfer Protocols and Reports.
• Generate and review procedures, protocols and reports.
• Proactively identify areas for continuous improvement in processes and procedures and lead these initiatives.
• Collaborate closely with Interdepartmental MSAT, ASAT, and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualification.
• Perform additional duties as assigned.

Skills

GMP QC experience

Cross-functional collaboration

Analytical problem-solving

MS Office proficiency

Education

BS in biology or related field

Tools

Flow cytometry

qPCR/dPCR

ELISA

LIMS/ELN

Job description

GeneFab seeks an experienced QC Analytical Analyst to support GMP QC testing, method transfers, qualification, troubleshooting, and investigations in a fast-paced cell therapy environment.

The role partners with Analytical Development, QC Operations, and manufacturing teams to ensure compliance, data integrity, and timely release of products. Strong data analysis and problem-solving are essential, as are attention to detail and teamwork.