Lab Research Supervisor, Quality Control and 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.

Apply By Date: 6/17/026 by 11:59pm

Minimum Qualifications - For full consideration, applicants are encouraged to upload license and/or certification if required of the position

• 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

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.

If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html

• High quality and low-cost medical plans to choose from to fit your family's needs
• UC pays for Dental and Vision insurance premiums for you and your family
• Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave
• Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Access to free professional development courses and learning opportunities for personal and professional growth
• WorkLife and Wellness programs and resources
• On-site Employee Assistance Program including access to free mental health services
• Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
• Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
• Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here

Physical Demands

• Standing - Frequent 3 to 6 Hours
• Walking - Frequent 3 to 6 Hours
• Sitting - Frequent 3 to 6 Hours
• Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
• Lifting/Carrying 26-50 lbs - Occasional Up to 3 Hours
• Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours
• Pushing/Pulling 26-50 lbs - Occasional Up to 3 Hours
• Bending/Stooping - Occasional Up to 3 Hours
• Squatting/Kneeling - Occasional Up to 3 Hours
• Twisting - Occasional Up to 3 Hours
• Climbing (e.g., stairs or ladders) - Occasional Up to 3 Hours
• Reaching overhead - Occasional Up to 3 Hours
• Keyboard use/repetitive motion - Continuous 6 to 8+ Hours

Environmental Demands

• Chemicals, dust, gases, or fumes - Frequent 3 to 6 Hours
• Loud noise levels - Occasional Up to 3 Hours
• Marked changes in humidity or temperature - Frequent 3 to 6 Hours
• Microwave/Radiation - Occasional Up to 3 Hours
• Operating motor vehicles and/or equipment - Occasional Up to 3 Hours
• Extreme Temperatures - Occasional Up to 3 Hours
• Uneven Surfaces or Elevations - Occasional Up to 3 Hours

Mental Demands

• Sustained attention and concentration - Continuous 6 to 8+ Hours
• Complex problem solving/reasoning - Frequent 3 to 6 Hours
• Ability to organize & prioritize - Continuous 6 to 8+ Hours
• Communication skills - Continuous 6 to 8+ Hours
• Numerical skills - Frequent 3 to 6 Hours
• Constant Interaction - Frequent 3 to 6 Hours
• Customer/Patient Contact - Occasional Up to 3 Hours
• Multiple Concurrent Tasks - Frequent 3 to 6 Hours

Work Environment

UC Davis is a smoke and tobacco free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e-cigarettes) will be strictly prohibited on any UC Davis owned or leased property, indoors and outdoors, including parking lots and residential space.

This position is designated as a critical position under UC policy and is contingent upon successful completion of a criminal background check and any required medical surveillance clearance.

• Must comply with all GMP, GLP, GDP, and institutional compliance requirements.
• May be required to work occasional evenings, weekends, or extended hours to support manufacturing campaigns or regulatory deadlines.
• Position requires work in cleanroom environments while fully gowned in accordance with aseptic processing standards.
• Must adhere to all safety requirements related to handling biological materials, chemicals, and radiation-producing devices.
• This position is designated as a mandated reporter under CANRA and must comply with applicable reporting requirements.
• Must adhere to UC Davis Health confidentiality, compliance, and data security policies.

Special Requirements - Please contact your recruiter with questions regarding which activities apply by position

• This is a critical position, as defined by UC Policy and local procedures, and as such, employment is contingent upon clearing a criminal background check(s) and may include drug screening, medical evaluation clearance and functional capacity assessment
• This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

A Culture of Opportunity and Belonging

At UC Davis, we're committed to solving life's most urgent challenges and building a healthier, more resilient world. We believe in growing through every challenge, continually striving to improve, and welcoming new perspectives that strengthen our community. We recognize that a vibrant and innovative organization values both individual strengths and shared purpose. The best ideas often emerge when people with different experiences come together.

As you consider joining UC Davis, we invite you to explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education. We believe you belong here. The University of California, Davis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

To view the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

Because we want you to feel seen and valued, our recruitment process at UC Davis supports openness and authenticity. Research shows that some individuals hesitate to apply unless they meet every qualification. You may be an excellent fit for this role-or the next one. We encourage you to apply even if your experience doesn't match every listed requirement. #YouBelongHere

To learn more about our background check program, please visit: https://hr.ucdavis.edu/departments/recruitment/ucd/selection/background-checks