Cell Therapy Manufacturing Associate III

University of Colorado•Aurora, CO

2d•Onsite

About The Position

This position is a full-time, subject matter expert-level position at the Gates Institute Biomanufacturing Facility (GBF) located on the CU Anschutz campus and serves on the Cell Therapy Manufacturing team. This position will be responsible for implementing operations, maintaining the cGMP facility, and properly executing procedures at the GBF to meet client and cGMP requirements. The facility is a mission-based facility for the development, manufacture, testing, and distribution of cell-based products for patient administration. This role will be a subject matter expert in the execution of cGMP Cell Therapy manufacturing and systems. This position will require experience related to general biology/chemistry and/or medical/hospital laboratory techniques.

Requirements

Bachelor’s degree in microbiology, Cell Biology, Bioengineering, Chemistry, Chemical Engineering, Molecular Biology or related field.
A combination of education and related technical/military/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis, but not for the specific experience.
4+ years of experience in a cGMP, biotechnology, or pharmaceutical setting.
2+ years of experience with aseptic cell isolation, expansion, manipulation, and/or cryopreservation techniques.
Applicants must meet minimum qualifications at the time of hire.

Nice To Haves

4+ years’ experience related to cell-based therapeutics, with an emphasis on CAR-T, TCR, blood, or IPSCs based therapies.
Experience in supporting written deviations and conducting investigations.
Experience working with FDA CFRs related to cell processing.

Responsibilities

Monitor and maintain processing and testing supplies, equipment, and facilities: disinfection and sterilization of tools, materials, and equipment; stocking supplies; preparing packaging, labeling, and documentation. This will include routine handling and lifting of laboratory supplies and bench-top equipment.
Implementation of Phase I manufacturing and analytical operations of cell-based products at the facility.
Perform work inside and outside of clean room environment (ISO 5, ISO 7, and ISO 8).
Document manufacturing operations using Good Documentation Practices, including maintaining laboratory notebooks, GMP documents, logs, and computer databases.
Manage tasks to meet project expectations related to timelines, budget, and quality.