GMP Program Manager

The GMP Program Manager is a leadership member of the Stem Cell Program, Good Manufacturing Practice (GMP) team and reports to the Stem Cell Program, Program Manager with a dotted line (for compliance responsibilities) to the Stem Cell Program Director (Dr. Nolta). UC Davis Health is investing in Cell and Gene Therapy across the School of Medicine and Medical Center. This position is tightly aligned with the goals of the implementation of this 10-year business plan for this UCDH-level strategic initiative.

The position provides complex project leadership related to the GMP's growth projections including managing projects to ensure operational optimization. To provide effective project and contract management, the incumbent analyzes and recommends novel solutions, interprets policies regarding operational management to ensure optimal efficiency and work product, oversees timelines, and applies subject matter knowledge in manufacturing. The position will be responsible for fostering and managing internal and external partnership and apply evidenced-based project management expertise to organize multiple workstreams simultaneously. Related to internal and external projects, responsibilities include operating expense/revenue budgets, supply chain management and equipment procurement, and the creation and distribution of operational reports. Incumbent manages projects primarily for the GMP, but the portfolio may span multiple CGT teams including preclinical and clinical research, as well as contracts, grants and corporate sponsors associate with the broader Cell and Gene Therapy Initiative.

Additional responsibilities are to provide leadership of the Quality Assurance team, including the design/refinement of supply management processes, laboratory management, and the preparation of operational reports regarding compliance with departmental goals and objectives. The incumbent will work closely with School of Medicine (SOM) Dean's Office, SOM Finance Unit, sponsoring entities, Sponsored Programs (SPO), UC Davis Health Contracts and Information Technology resources to develop written guidelines, procedures and policies to ensure efficiency, consistency and compliance with UCDH administrative regulations and requirements for the various projects.

Apply By Date: 8/19/2025 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 related area and/or equivalent experience/training.
• At least seven years of experience in cell and gene therapy manufacturing.
• At least two years of experience in a customer facing commercial role.
• At least two years of experience managing client projects.
• At least two years applying evidence-based project management tools and methodologies.
• At least two or more years of tissue and cell culture experience, including cell lines, primary cells, MSC, iPSC, and HSC.
• Experience managing a large, very complex, multifaceted department, or business unit.
• Experience supervising and managing a diverse group of employees.
• Experience in research laboratory supply management.
• Extensive experience in strategic planning.
• Expertise in relationship management, including supervisory experience in an academic setting.
• Extensive track record in project management and a strong background minimum 10 years in human stem cell and gene therapy products
• Ability to assess complex project opportunities, and analyzing project timelines, resources, and budget information with demonstrated knowledge of grant funding processes and procedures
• Demonstrated skills with technical documentation and CMC preparation for acceptance by regulatory and Federal Agencies for the purpose of IND submission.
• Knowledge of cell and gene therapy manufacturing workflows and project stages
• Client facing knowledge and ability to interface between internal and external stakeholders
• Demonstrated ability to work selflessly in a service role, to help multiple investigators, rather than to focus on a preferred project. High level of experience in cell biology and advanced molecular biology techniques.
• Knowledge of operating under FDA-compliant procedures and methods to obtain data for prePre-IND, Pre-IND, and IND applications
• Demonstrated ability to work independently, with emphasis on the ability to closely follow SOPs.
• Ability to organize data, and maintain accurate records
• Demonstrated organization skills to set work priorities with pressure of deadlines.
• Excellent interpersonal and communication skills, both verbal and written, to understand and appropriately respond to multiple and frequent inquiries, requests, and instructions in a courteous, cooperative, and professional manner.
• Advanced level of supervising staff and students in an academic or research setting.
• Academic background in relevant area of research.
• Ability to build relationships, collaborate and problem solve both internally and with external organizations.
• Demonstrated knowledge of program development as well as project proposal development and administration.
• Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution.
• Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders.
• Knowledge of human resources management practices and policies.
• Knowledge of financial principles and budget practices.

Preferred Qualifications

• Doctoral degree in a related field
• At least three years of experience in an academic health care setting.
• Five or more years managing client projects.
• Five or more years managing academic core operations.
• Five or more years of tissue and cell culture experience, including cell lines, primary cells, MSC, iPSC, and HSC.
• Experience with BUA and SCRO submissions, amendments, and maintenance.
• Advanced experience with GMP quality management systems.
• Extensive experience with and understanding of the Health System organization and executive administrative leadership.
• Advanced ability and/or skills to develop and review complicated, multi-year, multi-funded projects budget in accordance with sponsor guidelines.
• Demonstrated ability and/or skills creating and formatting spreadsheets and databases.
• Knowledge or ability to understand University fund accounting, generally accepted accounting principles and government auditing standards.
• Knowledge of University contracts/grants, financial, accounting and payroll policies and procedures.
• Demonstrated knowledge university, state, and federal policies that influence higher education.

Key Responsibilities

• 55% - Project Management and Contracts Management
• 30% - Quality Control Operations Supervision
• 15% - GMP Facility & Inventory Management

Department Overview

The Good Manufacturing Practice Facility (GMP) is a recognized as the largest academic GMP in Northern California. The GMP team reports to Stem Cell Program leadership; the Stem Cell Program is an internationally recognized basic, translational science and clinical research program committed to finding treatments and cures for debilitating human diseases and injuries utilizing the full range of human stem cells. The program includes affiliates from numerous departments across the Sacramento and Davis campuses. 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 treatments and clinical trials, and to perform scholarly research and development when appropriate.

Department Specific Job Scope

The GMP is dedicated to the production of clinical-grade stem cell therapies, gene therapy products, and pharmaceutical formulations for use in clinical trials and novel or routine patient treatments. Operating under strict regulatory standards, the facility ensures compliance with current Good Manufacturing Practices (cGMP) while supporting translational research, product development, and technology transfer. In addition to manufacturing, the facility contributes to scholarly innovation by advancing biomanufacturing methods and collaborating with investigators to bring promising therapies from bench to bedside.

POSITION INFORMATION

• Salary or Pay Range: $102,400.00 - $202,400.00
• Salary Frequency: Monthly
• Monthly Salary: $8,533.33 - $16,866.66
• Salary Grade: Grade 25
• UC Job Title: ACAD PRG MGT SUPV 2
• UC Job Code: 006832
• 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
• This is not an H-1B opportunity

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 - Occasional Up to 3 Hours
• Walking - Occasional Up to 3 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
• Pushing/Pulling over 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
• Reaching overhead - Occasional Up to 3 Hours
• Keyboard use/repetitive motion - Frequent 3 to 6 Hours

Environmental Demands

• Chemicals, dust, gases, or fumes - Occasional Up to 3 Hours
• Loud noise levels - Occasional Up to 3 Hours
• Operating motor vehicles and/or equipment - Occasional Up to 3 Hours
• Uneven Surfaces or Elevations - Occasional Up to 3 Hours

Mental Demands

• Sustained attention and concentration - Frequent 3 to 6 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 - Continuous 6 to 8+ Hours
• Customer/Patient Contact - Continuous 6 to 8+ Hours
• Multiple Concurrent Tasks - Continuous 6 to 8+ 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.

Non-smoking workplace. Occasional overtime may be required. The position is subject to a criminal background investigation

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