Cell Therapy Analytical Development Scientist

at  University of Colorado

JOB SUMMARY:

The Cell Therapy Analytical Development Scientist is a full-time, subject matter expert-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Cell Therapy Analytical Development team. This position will be responsible for developing, implementing and transferring analytical methodologies with an emphasis on new flow cytometry assays to meet internal project and external client requirements for the manufacture, testing, and distribution of cell-based products for patient administration. Aspects of the position will require project management, contributing to project teams, and interfacing with clients. This position requires experience related to all aspects of flow cytometry: generating and processing samples, designing and executing complex flow panels, acquiring and analyzing data and results from a variety of human and murine derived cell populations. This position engage highly with the Translational Sciences and Quality Control groups. This position will report to the Associate Director of Cell Therapy Analytical Development.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in Biological Sciences, Chemical Engineering, or related field.
• At least 3 years of expertise related to cell-based therapeutics
  A combination of advanced degree and related technical/professional experience may be substituted for the bachelor’s degree on a year-for-year basis.
  Applicants must meet minimum qualifications at the time of hire.

PREFERRED QUALIFICATIONS:

• Master’s Degree or equivalent experience in Cell Biology, Bioengineering, Chemical Engineering, or related field.
• At least 5 years of experience related to cell-based therapeutics.
• At least 4 years of experience working in a cGMP manufacturing setting related to biological and/or cell therapy drugs intended for human use.
• Experience with qRT-PCR, dd/dPCR, ELISA, cell-based assays, cell viability assays, and/or fluorescence microscopy.
• Experience with the isolation, culturing and performing aseptic cell culture manipulations for a variety of human-derived cell populations. Experience culturing and manipulating human-derived iPSC is a plus.
• Experience working in a start-up environment with a track record of being both team-oriented and a self-starter capable of operating independently.
• Prior direct supervision of technical staff.

KNOWLEDGE, SKILLS AND ABILITIES:

• Expertise in flow cytometry
• Expertise in mammalian cell culture
• Demonstrated success in technology transfer and qualification of complex analytical methods.
• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Capable of working as an individual or in a team setting.
• Motivated self-starter capable of operating in a start-up environment

• Act as the subject matter expert for flow cytometry, qPCR, and/or any novel methods of analytical assessment within the Gates Institute product pipeline.
• Serve as technical lead for the transfer of analytical assays from internal and external clients to the manufacturing facility.
• Independently design, execute, and critically analyze experiments and interpret complex data sets.
• Work closely with the research, translational sciences, and Quality Control labs to develop an analytical development plan, release paradigm, and specifications for each product candidate.
• Assist QC with all aspects of assay implementation, including protocol and SOP writing, and training staff.
• Author sections of Development and Production Reports, Batch Production Records, and Chemistry, Manufacturing, and Control sections of INDs.
• Manage tasks to meet project expectations related to timelines, budget, and quality.
• Generate and maintain laboratory notebooks, logs, inventories, and computer databases.
• Assist in monitoring and maintaining processing and testing equipment, facilities, and ordering supplies. This includes routine handling and lifting of laboratory supplies and bench-top equipment, and regular cleaning of laboratory facilities, supplies, and equipment.