Cell Therapy Manufacturing Associate III

About the role

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.

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.

Requirements

• Minimum Qualifications: Bachelor’s degree in microbiology, Cell Biology, Bioengineering, Chemistry, Chemical Engineering, Molecular Biology or related field.
• 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.

Qualifications

• 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.

Skills

• 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.
• Capable of working as an individual or in a team setting.
• Motivated self-starter capable of operating in a start-up environment.

Benefits

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 15/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

Why work for the University?

The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options
• Dental: Multiple plan options
• Additional Insurance: Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 15/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service