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Skills: Aseptic cell culture, GMP, GLP, Process development, SOP writing
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Summer 2027 Internship - RA/QA - Quality Assurance - California
Fremont, California, United States · On-site
$20/hr–$35/hr
Entry level
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Respiratory Sales Specialist / Point of Care Specialist
Irvine, California, United States · Hybrid
$101k–$167k/yr
Senior
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination …
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Full-time
bachelor degree
Medical insurance, Sick time, Vacation time, Retirement savings plans
Posted 11d ago
Apply by Oct 30
~40 hrs/week
Responsibilities
The specialist serves as a technical bridge between innovation and clinical-scale production, overseeing process transfer, validation, and optimization. They are also responsible for leading root-cause investigations, mentoring junior staff, and ensuring compliance with cGMP guidelines.
Requirements
Candidates must hold a Bachelor's degree in a relevant science field and possess at least 3 years of experience in aseptic cell culture. A strong understanding of GMP/GLP procedures and experience working within ISO cleanroom environments is mandatory.
Full job description
Who We Are
Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.
The School of Medicine has recently completed construction on a new cGMP Facility, following Current Good Manufacturing Practices (cGMPs). A cGMP facility is a production facility for the manufacturing of pharmaceutical or cellular products. It includes the manufacturing space, the storage warehouse for raw and finished product and support laboratory areas, including quality control and quality assurance programs, to control collection, processing, storage and release of cell therapy products. At UCI, the cGMP facility will enable clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells. The facility includes a seven-room GMP cellular therapy and viral vector facility, with an adjacent quality control laboratory.
Your Role on the Team
Reporting to the cGMP MSAT Manager, the candidate serves as the critical technical bridge between bench-top innovation, process development, analytical development, and clinical-scale production. In this role, the candidate will provide advanced technical oversight to ensure the seamless transfer, validation, and optimization of both manufacturing processes and analytical methodologies, including but not limit to large-scale productions of 20–40L. The ideal candidate will lead process scale-up initiatives, integrate robust analytical assays for process monitoring, evaluate production data for consistency, spearhead root-cause investigations for complex manufacturing deviations, and implement continuous improvement strategies to enhance product yield and operational efficiency.
Additionally, the candidate will be responsible for leading and mentoring junior specialists to ensure the flawless execution of all daily production and testing activities. To be successful, candidates must have a strong background in nonclinical/preclinical development for cell and gene therapies, alongside a proven ability to advance novel therapeutic approaches into clinical development. Exceptional expertise in aseptic behaviors and techniques is mandatory, as is a comprehensive understanding of analytical development frameworks and regulatory/workflow requirements within ISO 5, ISO 7, and ISO 8 cleanroom environments. This position requires hands-on experience creating, writing, and reviewing Standard Operating Procedures (SOPs), Batch Records, and technical protocols or regulatory filings to maintain strict compliance with global cGMP guidelines. Strong problem-solving skills, rigorous attention to detail, and a collaborative mindset are essential for success in this high-impact, cross-functional role.
What It Takes to be Successful
Required:
Academic background and experience in relevant area of research.
Ability to build relationships, collaborate and problem solve both internally and with external organizations.
Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders.
3+ years of aseptic cell culture (human primary cells and/or human cell lines) is required
General knowledge of GMP and GLP procedures
Experience in writing SOPs
Experience with Process Development
B.Sc. in science, biochemistry or equivalent.
B.Sc. degree with more than 3 years of relevant experience.
2 years of experience working in GMP facility preferred
Preferred:
Demonstrated experience supervising staff and students in an academic or research setting.
Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution.
Experience with bioreactors; AAV and TFF
Familiarity with regulatory affairs, quality control and production
Special Conditions:
Is required to lift up to 20lbs
Frequent walking; Some reaching, stooping, bending, kneeling, crouching
Tasks require focused attention to details
Must be able to work safely with chemicals and hazardous materials
Must be able to work overtime and flexible shifts
Total Rewards
In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.
Conditions of Employment:
The University of California, Irvine (UCI) seeks to provide a safe and healthy environment for the entire UCI community. As part of this commitment, all applicants who accept an offer of employment must comply with the following conditions of employment:
Background Check and Live Scan
Employment Misconduct
Legal Right to work in the United States
Vaccination Policies
Smoking and Tobacco Policy
Drug Free Environment
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.
The following additional conditions may apply, some of which are dependent upon business unit or job specific requirements.
The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti-Discrimination Policy.
We are committed to attracting and retaining a diverse workforce along with honoring unique experiences, perspectives, and identities. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable, and welcoming.
UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500 or [email protected].
Consideration for Work Authorization Sponsorship
Must be able to provide proof of work authorization
UCI Health is committed to providing the highest quality healthcare to Orange County and surrounding communities through its world-class physicians, surgeons and clinical staff.
UCI Health is the clinical enterprise of the University of California, Irvine. UC Irvine Medical Center, the main campus in Orange, California, features Orange County’s only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program, Level I trauma center and Level II pediatric trauma center. It is the primary teaching hospital for UCI School of Medicine.
Learn more about UCI Health: ucihealth.org
Job information: ucihealth.org/careers
Volunteer information: ucihealth.org/volunteer
Offices: 101 The City Dr S, Orange, California 92868, US · 101 The City Drive South, Orange, CA 92868, US · 1 Medical Plaza Drive, Irvine, CA 926997, US
CancerClinical TrialsNeurologyGeriatric MedicineCardiologyDigestive DiseaseWomen's HealthMaternityPrimary CareBariatric Surgery
How many Healthcare jobs are open in Irvine, CA right now?
There are currently 1,118 open healthcare positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Irvine, CA?
Companies currently hiring include UCI Health, Edwards Lifesciences, Allergan, City of Hope, Hoag Health System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Irvine, CA?
Yes — 203 of the 1118 open healthcare positions offer remote or hybrid work (68 remote, 135 hybrid).
How do I apply for Healthcare jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.