Senior QC Analyst – GMP & Method Transfer Lead

GeneFab; Alameda (CA); On-site; USD 62,000 - 76,000; Full time

Job summary

GeneFab, a California-based contract manufacturing and synthetic biology biofoundry, seeks an experienced QC Analytical Analyst to support GMP testing and method transfers for cell and gene therapy products.

The role focuses on QC testing, troubleshooting, investigations, and documentation to ensure cGMP compliance while coordinating with Analytical Development, MSAT, and Manufacturing teams in a fast-paced setting.

Qualifications

• B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field.
• Minimum of 5+ years of GMP/QC Laboratory experience.
• Demonstrated ability to collaborate and work in cross-functional teams.
• Strong organizational skills and attention to detail.
• Strong time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Experience with technologies such as multicolor flow cytometry, cell culture, multiplexed immunoassay, qPCR, dPCR methods, Luminex, and ELISA.
• Experience in GMP.
• Experience with contract laboratories and/or CDMO is a plus.
• Knowledge of LIMS and ELN is a plus.
• Proficient in MS Word, Excel, Project, and PowerPoint.
• Experience with cell therapy or gene therapy is a plus.
• Availability to work extended hours to meet deadlines when necessary.
• Comfortable in a fast-paced environment with minimal direction.

Responsibilities

• Provide technical SME support to Analytical Development and QC Analytical Operations.
• Develop, implement, and update QC SOPs, testing records, and documentation for cGMP compliance.
• Perform QC testing on in-process and final product samples to support release and stability testing.
• Lead root-cause investigations for aberrant results and deviations in analytical methods.
• Train junior employees to ensure testing procedures meet regulations and procedures.
• Plan and execute analytical method transfers, qualifications, and validations.
• Draft, review, and approve Method Transfer Protocols and Reports.
• Generate and review procedures, protocols and reports.
• Identify and lead continuous improvement initiatives in processes and procedures.
• Collaborate with MSAT, ASAT, and Manufacturing to support method optimization and transfers.
• Perform additional duties as assigned.

Skills

GMP experience

Cross-functional collaboration

Attention to detail

Time management

Analytical thinking

Ability to work extended hours

Education

B.S. in biology or related field

Tools

Flow cytometry

qPCR

dPCR

Luminex

ELISA

LIMS

ELN

Job description

GeneFab, a California-based contract manufacturing and synthetic biology biofoundry, seeks an experienced QC Analytical Analyst to support GMP testing and method transfers for cell and gene therapy products.

The role focuses on QC testing, troubleshooting, investigations, and documentation to ensure cGMP compliance while coordinating with Analytical Development, MSAT, and Manufacturing teams in a fast-paced setting.