Senior. Professional Research Assistant, cGMP Cell Therapy Manufacturing Associate
Charles C. Gates Biomanufacturing facility
Senior Professional Research Assistant
Working title: Senior Professional Research Assistant – cGMP Cell Therapy Manufacturing Associate III
The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.Nature of WorkThe selected candidate will be responsible for executing cGMP operations and providing guidance to junior operators at the newly established Gates Biomanufacturing Facility. The facility is a mission-based facility for the manufacture, testing, and distribution of cell-based products for patient administration.Professional FieldThis position requires experience related to performing cGMP operations for the production of cell-based therapy, such as chimeric-antigen receptor T-cell therapy, using cell culture, cell separations, aseptic cell culture manipulations, and general processing techniques. Supervision ReceivedThis position reports directly to the Cell Therapy operation lead at the Gates Biomanufacturing Facility.Examples of Work Performed:
- Full-time position at the Gates Biomanufacturing Facility located nearby the University of Colorado Anschutz Medical Campus.Execution of cGMP operations for the production of cell therapy products with additional guidance to junior operators conducting similar cGMP activities.
- Providing leadership in areas of GDP documentation, Batch Record execution, and deviation management. Maintains cleanliness required of the cGMP suite, equipment, work areas, and facility with assistance of other personnel. Prepares manufacturing suites and components for Production Batch Record execution. Perform aseptic cell culture on a routine basis.Manage, monitor and maintain processing and testing equipment, facilities, and supplies. This will include routine handling and lifting of laboratory supplies, and bench-top equipment and regular cleaning of facility, supplies, and equipment.
- Manage tasks to meet project expectations related to timelines, budget, and quality.Lead and train Cell Therapy staff to achieve operational, schedule, and quality requirements, with a particular emphasis on GMP operations.
- Provide exceptional customer service to users of the facility.
- Work in a professional and collaborative manner with coworkers and prospective users.
- Master’s Degree or equivalent experience in Cell Biology, Bioengineering, Chemistry, Molecular Biology, or related field or 10 years of experience as A Sr. PRA
- cGMP manufacturing experience in a biotechnology or pharmaceutical setting
- Knowledgeable in FDA CFRs related to cell processing
- cGMP manufacturing experience in a biotechnology or pharmaceutical setting. The candidate’s technical cGMP experience must be sufficient to enable leadership for more junior staff.
- Experience culturing and performing aseptic cell culture manipulations for a variety of human-derived cell populations.
- Ability to work in a start-up environment with a track record of being a team-oriented, self-starter capable of operating independently.
- Experience operating and maintaining cell/tissue culture equipment and overall facilities.
- Good communication skills
- Ability to accommodate a flexible manufacturing schedule
- cGMP manufacturing experience in a biotechnology or pharmaceutical setting.
- At least 2 years of experience related to cell-based therapeutics is preferred, with an emphasis on CAR-T, TCR, blood, or IPSCs based therapies.
Job Category: Faculty
Primary Location: Aurora
Posting Date: Feb 19, 2021
Unposting Date: Ongoing