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 partner.
Job Summary Final Filing Date : 11/28/20 Salary Range : $2,613.03 to $5,245.21 Salary Frequency : Bi-weekly Appointment Type : Career Percentage of Time : 100% Shift Hour : Varied Location : Stem Cell City : Sacramento Union Representation : No Benefits Eligible :Yes
We offer exceptional employment benefits including medical, dental, and vision plans, generous paid vacations and holidays, excellent retirement savings and investment plans, continuing education, and reduced fee and scholarship programs.
THIS IS NOT AN H1- B OPPORTUNITY
Responsibilities The Academic Program Management Officer (APMO) III or Quality Control Manager for the Good Manufacturing Practice Facility at the UC Davis Health campus in Sacramento will be responsible for highly complex and specialized manufacturing of cellular products for early phase clinical trials. In addition, this individual will be responsible for supporting the daily operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual will report to the GMP Facility Manager. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies. The individual filling this position will manage portions of GMP projects while applying project management knowledge, technical and interpersonal skills, and techniques to manage a variety of responsibilities while supervising and directing junior staff to achieve project goals.
Advanced MS degree with 3-5 years of related experience in a science related field or in Biotech/Pharmaceutical industry or an equivalent combination of education and experience.
Experience in a Quality Control role under GMP compliance supporting biologic products.
Strong knowledge base with Good Manufacturing Practices (cGMPs, GLPs, GDPs e.g., FACT and FDA).
Experience with Standard Operating Procedures in a GMP laboratory setting.
Advanced MS degree preffered.
Supervisory experience Previous working experience in a GMP/GLP environment Experience managing complex projects is required as well and demonstrated Project Management Skills Regulatory compliance and requirements pertaining to GMP practices.
Knowledge in cell and gene therapy, or previous working experience in a lab or as a cell technician.
Advanced knowledge of cell culture, cell line development, bioreactor operation and scale-up, centrifugation and ultracentrifugation, tangential flow and normal flow filtration.
Expert in flow cytometry, protein, mRNA, DNA characterization
Special Requirements This position may be subject to a criminal background investigation, drug screen, Live Scan fingerprinting, medical evaluation clearance, and functional capacity assessment.
EEO The University of California is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination policy.
The University of California is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. 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 nondiscrimination policy.
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UC Davis is the home of the Aggies — go-getters, change makers and problem solvers who make their mark at one of the top public universities in the United States. Since we first opened in 1908, we’ve been known for standout academics, sustainability and Aggie Pride as well as valuing the Northern California lifestyle. These themes are woven into our 100-plus-year history and our reputation for solving problems related to food, health, the environment and society.Our 5,300-acre campus is in the city of Davis, a vibrant college town of about 68,000 located in Yolo County. The state capital is 20 minutes away, and world-class destinations such as the San Francisco Bay Area, Lake Tahoe and the Napa Valley are within a two-hour drive.