Staff Research Associate 3: HSC Technician (SRA 3)

This position is for a technical expert in the area of Autologous Hematopoietic Stem Cell Gene Modification Manufacturing within the Stem Cell Program who - within the most complex technical areas - develops new procedures, modifies standard methodologies, formalizes standard operating procedures, collects and extrapolates data on new methodologies to develop test criteria and standards; instructs other laboratory personnel in the performance of new/modified procedures; operates the most sophisticated equipment that requires in-depth subject matter knowledge; discusses with physicians the merits of a particular test; may suggest alternate methods of verifying test results; answers the most difficult questions; and performs laboratory research and design efforts. The incumbent will manufacture clinical-grade cell and gene therapy products for ongoing clinical trials with the highest level of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) standards. These objectives are to be met within the limits of resources available with emphasis on cost effectiveness and innovation.

The incumbent is required to train researchers and graduate students. This position is responsible for advancing stem cell therapies toward clinical trials through close interaction with team members and maintaining Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. They will research and independently develop methods to translate findings and new advances into clinical applications and will maintain and supervise GLP/GMP processes as required by the FDA to allow translation of novel stem cell therapies into clinical trials. The incumbent will consult with the academic supervisor and other academic or professional researchers on the nature and overall objectives to be achieved and advise them on the more difficult and problematic areas that they may encounter and suggest solutions. They will continue to contribute significant original and innovative ideas of judgment and discretion, initiative, and resourcefulness in making decisions about the research, will author and co-author findings and newly developed methods in peer reviewed scientific journals, and will present at scientific meetings and symposia.

Apply By August 14, 2024 @ 11:59 PM

Qualifications

Minimum Qualifications

• Masters Degree in Biological Sciences or related field and/or equivalent education, training, and experience.
• 5+ years of experience working in the field of stem cell and gene therapy translational and clinical research using the Good Laboratory Practice (GLP) framework.
• Degree in Cell Biology or similar field
• Experience managing animal studies and working with cellular products. Knowledge of GLP and GMP practices, protocols.
• Experience with technical reporting, data reliability, interpretation, and documentation.
• Experience with administrative/ business software, computer systems, database, web/email applications.

Preferred Qualifications

• Experience working with Hematopoietic stem cells and gene therapy/ transduction.
• Experience and proven ability to conduct mouse transplantation.

Key Responsibilities

• 40% - Cell and Gene Therapy Manufacturing and Regulatory Compliance
• 55% - IND-Enabling Animal Studies
• 5% - Miscellaneous

Department Overview

The UC Davis Institute for Regenerative Cures, Stem Cell Program is a basic and translation science and research center committed to finding treatments and cures for debilitating human diseases and injuries using human stem cells and a variety of biomedical engineering techniques.

Department Specific Job Scope

This position will work in the Shared Translational Laboratory and in the Institute for Regenerative Cures Vivarium, and in the GMP facility. The incumbent will closely coordinate with the Stem Cell Program's Quality Control Testing Laboratory for testing of novel cell and gene therapy clinical investigational products and will coordinate with the UC Davis Alpha Stem Cell Clinic (ASCC). This incumbent supports departmental goals through the performance of accurate quality control execution within the limits of strict timelines and responsible resource stewardship. The incumbent is responsible for ensuring all federal, state, and local regulatory requirements are adhered to during the course of this work. This position is responsible for planning, execution, data collection, and reporting of pre-clinical studies and is expected to contribute to a variety of research projects associated with the Stem Cell Program including the Sickle Cell disease team. This position is integral to current and future disease team grants and program project funding and to the success of the Stem Cell Program in finding novel treatments to save the lives of patients with currently incurable diseases using a high level of teamwork.

The incumbent will support the goals of the Stem Cell Program and Sickle Cell disease team by coordinating and performing GMP product manufacturing for future clinical use and will operate in the development and execution of multi-disciplinary projects and perform state-of-the-art, complex research projects in collaboration with faculty, Academic Supervisors, staff, students, and volunteers. They will coordinate and perform studies to obtain the data required for the Investigational New Drug (IND) submission to the FDA, as well as new funding opportunities. The incumbent will conduct IND-enabling studies in immune deficient animal models using pre-clinical or clinical grade stem cell and other cellular therapy products, gene therapy products and formulations for novel or routine future patient treatments and clinical trials, and to perform scholarly research and development when appropriate.

POSITION INFORMATION

• Annual Salary or Pay Range: $66,437.42 - $106,832.28
• Salary Frequency: Biweekly
• Salary Grade: 105
• UC Job Title: SRA 3
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100%
• Shift Hours: 8 AM - 5 PM
• Location: UCD Inst for Regenerative Cure (HSP041)
• Union Representation: RX-Research Professionals
• Benefits Eligible: Yes
• Hybrid/Remote/Onsite: 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
* UC Davis cares about building a community, which is why we provide resources to enhance diversity, equity and inclusion as well as Employee Resource Groups (ERGs) to support our staff

Physical Demands

• Standing - Frequent 3 to 6 Hours
• Walking - Frequent 3 to 6 Hours
• Sitting - Occasional Up to 3 Hours
• Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
• Lifting/Carrying 26-50 lbs - Occasional Up to 3 Hours
• Lifting/Carrying over 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
• Climbing (e.g., stairs or ladders) - Occasional Up to 3 Hours
• Reaching overhead - Occasional Up to 3 Hours
• Keyboard use/repetitive motion - Occasional Up to 3 Hours

Environmental Demands

• Chemicals, dust, gases, or fumes - Frequent 3 to 6 Hours
• Loud noise levels - Continuous 6 to 8+ 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 - Frequent 3 to 6 Hours
• Extreme Temperatures - Occasional Up to 3 Hours
• Uneven Surfaces or Elevations - Frequent 3 to 6 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 - Occasional Up to 3 Hours
• Constant Interaction - Frequent 3 to 6 Hours
• Customer/Patient Contact - Continuous 6 to 8+ Hours
• Multiple Concurrent Tasks - Occasional Up to 3 Hours

Work Environment

* Position requires lifting up to 25 lbs.

* Work with a computer keyboard frequently throughout the day.

* Retrieve samples from shelves ranging in height from 6" to 72".

* Work at a lab bench for extended periods.

* Required to wear protective clothing for extended periods of time including gowns, gloves, masks, face shields. goggles, sleeves, head covers.

* Work under regular exposure to zoonotic diseases anesthetic agents, cleaning chemicals and radiation producing devices.

* Work independently, with emphasis on the ability to closely follow clinical policies and procedures

* Must be able to meet HIPAA compliance upon hire

* Must have a valid California driver's license

* Must be able to work a flexible schedule based on business needs; occasional overtime and weekends may be required

* Required travel for training and conferences.

* Position is subject to Medical Surveillance procedures and review in accordance with federal and state laws and regulations and University policy

Special Requirements

• This is a critical position, as defined by UC policy and local procedures, and as such, employment is contingent upon successful completion of background check(s), including but not limited to criminal record history background check(s)
• This is a positions with direct access to or responsibility for controlled substances, high risk hazardous chemicals, biological or radioactive/nuclear materials
• 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

Diversity, Equity, Inclusion and Belonging

At UC Davis, we're solving life's most urgent challenges to bring a fuller, healthier, and more resilient world within reach. We grow from every challenge we take on and we don't just maintain - we improve. We recognize that creating an inclusive and intellectually vibrant organization means understanding and valuing both our individual differences and our common ground. The most comprehensive solutions come from the most diverse minds and you belong here. As you consider joining UC Davis, please explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education, and our latest efforts to outgrow the expected. The University of California, Davis is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California's Affirmative Action Policy, please visit: https://policy.ucop.edu/doc/4010393/PPSM-20

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

Because we want you to be seen, our recruiting process at UC Davis fosters authenticity, diversity, and inclusion. Studies have shown that some people may not apply to jobs unless they meet every single qualification. Each unique role at UC Davis has a set of requirements and you could be perfect for this role, or you could be perfect for the next role! Don't meet all the requirements? We still encourage you to apply! #YouBelongHere #CA-CC #LI-CC1