Senior QC Specialist: Cell & Gene Therapy Method Transfer Lead

GeneFab; Alameda (CA); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

GeneFab in Alameda, CA is seeking a Senior Quality Control (QC) Specialist to perform GMP analytical testing in a CDMO setting for Cell Therapy and Gene Therapy products. The role includes method transfers, SOP development, and support for regulatory and client needs.

You will work cross-functionally with QC, QA, Manufacturing, and AD teams to support clinical and commercial tech transfer activities, while mentoring junior analysts in a fast-paced environment.

Qualifications

• 5+ years of GMP QC laboratory and Method Transfer experience in Cell Therapy/ Gene Therapy.
• Hands-on experience with cell therapy analytical methods (cell culture, flow cytometry, ELISA, dPCR, qPCR, cell-based assays).
• Strong understanding of GMP, ICH, USP, and regulatory requirements for biologics/cell therapies.
• CDMO/contract lab experience is a plus.
• Excellent organizational, communication, and leadership skills.
• Experience supporting clinical and commercial manufacturing.
• Proficiency in ELN, LIMS, and Veeva electronic systems.
• Comfortable in a fast-paced biotech environment with shifting priorities.
• Ability to foster accountability, quality, and continuous improvement.
• May support and/or perform analyst tasks on non-routine basis.

Responsabilités

• Provide technical expertise (SME).
• Support Saturday and Sunday GMP manufacturing operations.
• Plan, lead, and execute analytical method transfers, qualifications, and validations.
• Develop, implement, and update QC SOPs, test records and documentation for cGMP.
• Provide technical support to Analytical Development and QC Analytical Operations.
• Perform GMP analytical testing for in-process, release, characterization, and stability samples.
• Participate in laboratory investigations including OOS, OOT, deviations, errors, and CAPAs.
• Participate in Risk Assessments and Continuous Improvement initiatives.
• Draft, review, and approve Method Transfer Protocols and Method Transfer Reports.
• Generate and review procedures, protocols and reports.
• Lead continuous improvement initiatives in processes and procedures.
• Maintain laboratory readiness for inspections.
• Perform data review ensuring accuracy and ALCOA+ data integrity.
• Perform additional duties as assigned.

Connaissances

GMP knowledge

Analytical method transfer

Laboratory documentation

ALCOA+ data integrity

Formation

Bachelor’s degree in biology, chemistry, biochemistry, or related scientific discipline

Advanced degree (MS/PhD) in a related field

Outils

ELN

LIMS

Veeva

Description du poste

GeneFab in Alameda, CA is seeking a Senior Quality Control (QC) Specialist to perform GMP analytical testing in a CDMO setting for Cell Therapy and Gene Therapy products. The role includes method transfers, SOP development, and support for regulatory and client needs.

You will work cross-functionally with QC, QA, Manufacturing, and AD teams to support clinical and commercial tech transfer activities, while mentoring junior analysts in a fast-paced environment.