StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. Clinical trials are underway in Spinal Cord Injury and dry Age-related Macular Degeneration. StemCells also markets a range of stem cell research products under the SC Proven® brand, and offers contract cell process development and production services.
We are currently seeking a Manufacturing Associate to work in the GMP clean rooms manufacturing product for preclinical studies and clinical trials. This position reports to the Manager, GMP Manufacturing.
Responsibilities will include:
• Execute processes for the GMP culture-expansion and cryopreservation of stem cell and progenitor cell products for use in clinical trials according to the requirements of SOPs, batch production records and approved protocols and in compliance with GMP, GTP and ICH regulations
• Complete and Review batch production records to ensure cGMP documentation practices are followed and that information entered is complete and accurate
• Write and/or amend SOPs, batch production records, qualification and validation protocols, reports and other documentation
• As necessary, execute process, equipment, systems and utilities, qualification and validation protocols
• Other duties as may be assigned
StemCells, Inc. offers a comprehensive and competitive compensation package, as well as generous paid time off in addition to Company observed holidays, and Medical, Dental and Life Insurance. We promote a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.
For more information about StemCells, Inc., please visit http://www.stemcellsinc.com
To apply, please send your resume/CV to firstname.lastname@example.org, Subject: MFG- BSP or FAX your resume/CV to: Staffing at (510) 456-4001. No phone calls please.
Direct applicant only; no agencies, please. EOE
Candidate must possess:
• BS, MT (ASCP) or equivalent qualification
• 1 -3 years of relevant experience in clinical cell processing facility, GMP manufacturing operations in the cell therapy industry or cell culture operations in the biotechnology industry
• Experience with cell culture, aseptic/closed system processing methods and knowledge of current GMP and GTP regulations is required
• Knowledge of flow cytometric, density gradient and immuno-magnetic cell purification methods will be an advantage.
• Must be a motivated team player
• Must have excellent written and oral communication skills
• Must be willing to work flexible hours.