Job Code: SCI-MFG | Location: Mountain View CA – USA
Manufacturing Associate
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 Manufacturing Manager.
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.
- Writing 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
Education and Experience
Candidate must possess:
- A BS, MT (ASCP) or equivalent qualification
- 1 – 3 years of relevant experience in either a clinical cell processing facility or GMP manufacturing operations in the cell therapy industry
- Experience with cell culture, aseptic/closed system processing methods
- Knowledge of current GMP and GTP regulations is required
- Must have excellent written and oral communication skills
- Must be a motivated team player
- Must be willing to work flexible hours.