Assistant lab Jobs in Sacramento, CA

Lab Research Supervisor, Quality Control & Analytical Development

This position will serve as a Lab Research Supervisor, Quality Control & Analytical Development, for the Good Manufacturing Practice Facility at the UC Davis Health campus in Sacramento. The QC/AD Supervisor I provides direct supervision and technical leadership to Quality Control and Analytical Development staff supporting the manufacture of clinical-grade cell and gene therapy products within the UC Davis GMP Facility. This position oversees analytical method development, qualification/validation, release testing coordination, assay troubleshooting, and technology transfer activities under cGMP. The supervisor ensures QC testing platforms are scientifically robust, regulatory compliant, and scalable for early-phase clinical manufacturing and beyond. This role supervises QC/AD personnel, manages assay lifecycle activities, drives continuous improvement initiatives, and serves as subject matter expert (SME) for analytical strategy in client and regulatory interactions. This position reports to the GMP Program Manager and works closely with QA, Manufacturing, Regulatory Affairs, and external clients.

Minimum Qualifications:

• Bachelor's degree in Cell Biology, Molecular Biology, Biochemistry, Bioengineering, Pharmaceutical Sciences, or related scientific discipline and/or an equivalent combination of education and relevant professional experience.
• 1-3 years of progressive experience in a GMP-regulated Quality Control, analytical development, or process development laboratory supporting biological, cell therapy, or gene therapy products.
• Demonstrated experience in assay development, qualification, validation, and lifecycle management.
• Prior supervisory experience required or documented lead experience, formal supervisory training, or demonstrated oversight of technical personnel for entry-level supervisory consideration.
• Experience supporting deviation investigations, OOS/OOT events, and CAPA implementation in a regulated environment.
• Strong working knowledge of current Good Manufacturing Practices (21 CFR 210/211), ICH Q2 and Q6B, and USP testing standards applicable to biologic and cellular therapy products.
• Advanced analytical troubleshooting skills with the ability to identify root causes of assay variability and implement corrective actions.
• Demonstrated ability to supervise, mentor, and develop technical laboratory staff in a regulated environment.
• Strong data analysis skills with experience interpreting complex biological datasets and statistical outputs.
• Excellent written and verbal communication skills, including preparation of validation reports, investigation reports, and technical summaries.
• Ability to manage multiple concurrent projects, prioritize effectively, and meet critical deadlines in a fast-paced GMP setting.
• Proficiency with analytical and data software platforms such as FlowJo, GraphPad Prism, JMP, and Microsoft Excel.

Preferred Qualifications:

• Master's degree or advanced degree in Cell Biology, Molecular Biology, Biochemistry, Bioengineering, Pharmaceutical Sciences, or related scientific discipline.
• Advanced academic or professional training in analytical development, biostatistics, or regulated biomanufacturing preferred.
• Strong knowledge of cGMP (21 CFR 210/211), ICH Q2/Q6B, USP testing standards.
• Advanced troubleshooting and data analysis capability.
• Strong project management and cross-functional coordination skills.
• Excellent written and verbal communication skills.
• Experience with analytical software tools (FlowJo, GraphPad, JMP, Excel).
• Experience supporting autologous and/or allogeneic cell therapy manufacturing programs.
• Experience with viral vector characterization (e.g., AAV, lentiviral vectors) and/or gene editing technologies.
• Experience supporting IND filings, regulatory inspections, or FDA/FACT audits.
• Advanced experience with multi-color flow cytometry, ddPCR/qPCR, ELISA, and potency assay development.
• Demonstrated project management experience supporting cross-functional clinical manufacturing programs.
• Advanced knowledge of multi-parameter flow cytometry panel design and complex assay validation strategies.
• Experience applying statistical process control (SPC) and trending tools in GMP quality systems.
• Familiarity with electronic Quality Management Systems (eQMS).
• Experience contributing to regulatory submissions (IND/BLA) or responding to regulatory audit observations.

Key Responsibilities:

• 35% - QC & Analytical Operations Oversight
• 20% - Assay Development & Technology Transfer
• 15% - Assay Validation Leadership
• 15% - Investigations, OOS, CAPA & Trending
• 10% - Supervision & Staff Development
• 5% - Documentation & Continuous Improvement

Department Overview:

The Good Manufacturing Practice Facility (GMP) is a large operation within the Stem Cell Research Program at the UC Davis Health campus in Sacramento and is the largest academic GMP facility in Northern California. The purpose of the Good Manufacturing Practice (GMP) Facility is to manufacture clinical grade stem cell and other cellular therapy products, gene therapy products, pharmaceutical products and formulations for novel or routine patient treatment and clinical trials under strict adherence to FDA regulations. The GMP currently manufactures products for University investigators as well as other academic and industry partners.

Position Information:

• Salary or Pay Range: $2,666.40 - $4,758.40
• Salary Frequency: Bi-Weekly
• Salary Grade: Grade 21
• UC Job Title: LAB RSCH SUPV 1
• UC Job Code: 006246
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100%
• Shift (Work Schedule): Day
• Location: UCD Inst for Regenerative Cure (HSP041)
• Union Representation: 99 - Non-Represented (PPSM)
• Benefits Eligible: Yes

This position is 100% on-site