Manufacturing Project Lead
UC San Diego Health
Manufacturing Project Lead
Filing Deadline: Tue 6/1/2021
The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.
The Advanced Cell Therapy lab (ACTL) is a state of the art Current Good Manufacturing Practice (cGMP) manufacturing facility whose highly skilled team will support UC and local investigators transition novel therapies through the Investigational New Drug (IND) and Phase I/II clinical trials.
Manufacturing Lead will serve as a critical member of the Advanced Cell Therapy Laboratory (ACTL) and engage in complex projects that require original contribution. Responsibilities include conducting and overseeing cell therapy product manufacturing; planning and assigning work tasks. The Manufacturing Lead will perform a wide variety of product manufacturing activities that require ingenuity, resourcefulness and flexibility. the Manufacturing Lead will be responsible for key activities related to the manufacture, testing, and storage of Good Manufacturing Practice (GMP) products. Will ensure departmental compliance with related policies, standard operating procedures (SOP), and regulatory guidelines. Will contribute to evaluation and purchasing recommendations of laboratory equipment. Independently responsible for coordination of GMP cell culture and the associated assays within a laboratory and cleanroom.
Incumbent will analyze a broad range of laboratory activities in the support of cell therapy products under cGMP for use in pre-clinical & clinical studies. Will manage translational research and development and validation studies of processes and equipment as required. Will perform and oversee all associated ACTL procedures that are required to ensure the daily operation of the ACTL and to maintain licensing and accreditation, as indicated. Responsible for participating in the quality management and accreditation process. Responsible for coordination of the culturing activities for various cell therapy products, including the expansion of T cells, NK cells, neuronal cells, human pluripotent stem cells, and other cell types derived from donors.
• Bachelor's degree in related area plus four (4+) or more years experience/training preferably in a pharmaceutical manufacturing or academic environment.
• Demonstrated experience with aseptic cell culture methods, including cryopreserving, thawing, and expanding cell lines, is required.
• Extensive experience in a pharmaceutical, biotech, drug manufacturing, or academic environment is required, with knowledge of cleanroom practices being essential.
• Experience with protocol development, testing, and validation and with developing related Standard Operating Procedures (SOP). Ability to follow detailed instructions described in SOP and Batch Production Records and to record data accurately and in a legible manner per GMP requirements.
• Advanced experience with the Miltenyi CliniMACs or similar flow cytometry device, qPCR instruments, absorbance readers and other cell characterization equipment.
• Advanced understanding of cGMP and cGLP guidelines as well as demonstrated strong knowledge of FDA guidelines and regulations.
• Through knowledge of research methods and scientific principles.
• Superior computer skills including knowledge of PC software applications such as Word and Excel to produce manuscripts, reports, correspondence, graphs, and spreadsheets to generate, track, and analyze required data. Ability to navigate and utilize email systems and the internet.
• Willingness to adhere to established UCSD guidelines for safety and environmental issues.
• Theoretical background and knowledge in human pluripotent cell culture techniques, including culturing, maintenance, cryopreservation and differentiation.
• Experience making independent decisions, analyzing situations, problem solving, and initiating action for laboratory management. Proven ability to work independently and lead a team.
• Employment is subject to a criminal background check.
• Willingness to work in BioSafety Level II environment where biological (including infectious agents and blood borne pathogens) hazards are present.
• Willingness to work with human pluripotentstem cells, work with viruses that are infectious to humans, including adeno-associated viruses, Sendai viruses, and lentiviral vectors which are derived from human immunodeficiency virus (HIV).
• Willingness to work in environment where biological (including infectious agents and blood-borne pathogens), chemical, and radiological hazards are present, to perform research on the human pluripotent stem cell, to work with viruses that are infectious to humans, including adeno-associated viruses, Sendai viruses, and lentiviral vectors which are derived from human immunodeficiency virus (HIV).
• Must be able to work various hours and locations based on business needs.