University of Rochester Lab Tech cGMP Production in Rochester, New York
Full Time 40 hours Grade 079 Microbiology & Immunology M&D;
Provide ongoing support of the Upstate Stem Cell Current Good Manufacturing Practice (cGMP) Facility including: providing a key role for technology transfer, GMP process and analytical development, as well as GMP production and testing of cell-based therapies clinical trial materials. Under the general guidance of the facility Director and USCGF staff, with the expectation for proactive and independent work habits, this person will provide bench-level research and development support for ongoing programs.
The successful candidate will play an important role in the development, optimization and scale-up of cell culture processes, as well as the development and qualification of a variety of cell-based assays and bioanalytical methods. This individual is expected to make detailed observations, analyze data, interpret results, as well as prepare technical reports, protocols, and data summaries. The candidate will be expected to execute cell culture processes as well as QC testing of clinical trial materials in a GMP-compliant facility. The ability to follow policies and regulations ensuring GMP compliance is critical.
Under the guidance of USCGF staff specific responsibilities will include:
- Collaborate with multidisciplinary research teams involving process technology transfer and GMP process development. This person will modify existing research manufacturing processes and develop them for clinical-scale GMP purposes. This includes generation of all relevant documentation (Batch Records, Compounding Records, Operating Procedures, etc.).
- Collaborate with multidisciplinary research teams involving technology transfer for product-specific analytical test methods. This person will develop and qualify QC test methods for the release of clinical trial materials. This includes generation of all relevant documentation (Test Methods, Operating Procedures, Validation Protocols and Final Reports, etc.).
- Following FDA-approved GMP guidelines, this individual will be directly responsible for clinical-scale GMP manufacturing of cell therapy clinical trial materials. This will include ensuring adherence to GMP regulations by Customer Research Teams that are physically working in the GMP controlled manufacturing areas.
- This individual will be directly responsible for supplies and stock management within different programs.
- Collaborate with GMP staff in execution of ongoing environmental control and monitoring program. This includes facility cleaning and monitoring of clean room physical parameters as well execution and documentation of environmental monitoring (total air particulates, air viable counts, viable counts from settling plates and viable counts from contact plates).
- Minimum of an Associate’s degree in appropriate discipline plus 4-5 years specialized experience in related field, or equivalent combination of education and experience required.
- BS degree, significant experience with mammalian cell culture techniques, bioanalytical assays (ELISA and flow cytometry) and a background in cGMP principles and Quality Management Systems is desirable.
- Strong attention to detail and organizational skills.
- Ability to work both independently as well as collaborate with a team.
- trong interpersonal, presentation, and communication skills both verbal and written.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Lab Tech cGMP Production
Location: School of Medicine & Dentistry
Job ID: 214067
Full/Part Time: Full-Time