QC Lab Supervisor

GeneFab; Alameda (CA); On-site; USD 130,000 - 150,000; Full time

Job summary

GeneFab is looking for a highly motivated QC Laboratory Supervisor to lead weekend shift operations within our Quality Control laboratory. The candidate should have strong expertise in analytical testing and experience in a GMP-regulated environment, playing a critical role in ensuring quality and compliance.

Responsibilities include supervising daily lab operations, reviewing and approving testing activities, and collaborating with various departments to support product release. The position requires a Bachelor’s degree and a minimum of 5 years in Quality Control, with at least 1–2 years in a supervisory role.

Qualifications

• Minimum 5 years of experience in Quality Control in a GMP-regulated environment.
• At least 1–2 years in a supervisory or team lead role.
• Hands-on experience with cell therapy-related analytical methods like flow cytometry and ELISA.

Responsibilities

• Supervise daily operations of the QC laboratory including testing and data review.
• Support review and approval of Raw Materials, in-process, and release testing.
• Collaborate with cross-functional departments to support product release.

Skills

Analytical testing

Laboratory operations

Leadership in GMP environment

Quality control standards

Communication skills

Problem-solving

Education

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

Advanced degree (plus)

Tools

LIMS

Empower

Veeva

Job description

We are seeking a highly motivated, detail‑oriented, and collaborative QC Laboratory Supervisor to lead the weekend shift (Wednesday – Saturday) operations within our Quality Control laboratory supporting cell and gene therapy products. The ideal candidate will possess strong technical expertise in analytical testing and laboratory operations, demonstrated leadership experience in a GMP‑regulated environment, and a commitment to maintaining the highest standards of quality, compliance, and operational excellence.

This individual will play a key role in ensuring the timely execution of testing activities, supporting clinical and commercial manufacturing programs, and fostering a culture of continuous improvement, teamwork, and customer‑focused service.

Responsibilities

• Supervise daily operations of the QC laboratory, including testing, and data review for in‑process, release, and stability testing of cell therapy products.
• Support review and approval of:
  • Raw Materials data
  • In‑process testing
  • Release testing
  • Stability testing
  • Method transfer documentation
  • Qualification and validation protocols/reports
• Verify laboratory investigations, deviations, and OOS/OOT documentation are scientifically sound and properly documented.
• Support investigation of out‑of‑specification (OOS), out‑of‑trend (OOT), and deviation events. Assist with root cause analysis and implementation of CAPAs.
• Review laboratory notebooks, worksheets, electronic records, chromatographic data, calculations, and supporting documentation.
• Support batch disposition activities through timely QC documentation review.
• Coordinate scheduling of resources, lab activities, and shift coverage to meet production timelines.
• Review laboratory data, calculations, and documentation for accuracy and completeness.
• Approve test results and ensure timely data entry into LIMS or equivalent systems.
• Oversee maintenance and calibration of laboratory equipment and manage lab supply inventory.
• Support method qualification, transfers, and validation activities as needed.
• Collaborate cross‑functionally with Manufacturing, QA, AD, MSAT, and other departments to support product release and continuous improvement efforts.
• Author and revise QC SOPs, work instructions, protocols, and reports as needed.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, or related scientific discipline; advanced degree is a plus.
• 5+ years of experience in Quality Control in a GMP‑regulated environment, with at least 1–2 years in a supervisory or team lead role.
• Hands‑on experience with cell therapy‑related analytical methods such as flow cytometry, ELISA, qPCR, and cell‑based assays.
• Strong understanding of GMP, ICH, USP, and regulatory requirements applicable to biologics/cell therapies.
• Excellent organizational, communication, and leadership skills.
• Proficiency in electronic systems such as LIMS, Empower, and Veeva.
• Comfortable in a fast‑paced, dynamic biotech environment with shifting priorities.
• Demonstrated ability to foster a culture of accountability, quality, and continuous improvement.
• May need to support and/or execute analyst tasks on a non‑routine basis.

$130,000 - $150,000 a year

We welcome qualified candidates and are an equal opportunity employer.