University of Colorado Anschutz Medical Campus

Department: Gates Biomanufacturing Facility

Job Title: Quality Control Analyst II - HPLC

Position #:00803789 – Requisition #:37816

Job Summary:

This position is a full-time, subject matter expert-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Quality Control team. At the Analyst II level, position will perform independent routine analytical testing in a multidisciplinary laboratory space with a specific emphasis on analytical development. This position will also support analytical method qualification as well as release testing of protein biologics and regenerative medicine cellular therapies. This position will be expected to have a sufficient knowledge base regarding the analytical methodologies that they are routinely performing as well as basic Quality principes such as Good Documentation Practices (GDP) as well as Good Manufacturing Practices (GMP).

This role will act as a HPLC subject matter expert and will perform specialized testing and assay development for the Quality Control team. This position will focus on assay development and qualification apart from routine analytical testing in a multidisciplinary laboratory space in support of release testing of protein biologics and regenerative medicine cellular therapies.  All work will be completed within a GMP (21 CFR Part 210/211) Quality Control laboratory. This position may support method development.  This position will NOT support any academic research.

Key Responsibilities:

• Lead HPLC/UPLC and other methodology analytical method development and qualification efforts

• Perform protein biologic analytical tests to support cGMP batch release including HPLC/UPLC, DLS, pH, and UV-Vis spectrophotometry, ELISA, SDS-PAGE, Bioburden, Conductivity, Endotoxin, and Total Organic Carbon (TOC).

• Perform regenerative medicine cellular therapy analytical tests to support cGMP batch release including Product thawing, Cell Counting, Endotoxin, and Gram Stain.

• Perform additional regenerative medicine cellular therapy analytical tests to support cGMP batch release (Mycoplasma, Vector Copy Number, and Replication Competent Lentivirus qPCR analyses).

• Support in-process HPLC/UPLC testing to support Biologics process development.

• Perform compendial method suitability testing.

• Maintain Qualified Trainer status on three or more analytical methods.

• Maintain Subject Matter Expert in one or more analytical methodology.

• Establish control charts and other metrics for the monitoring and improvement of QC analytical methods

• Refine and implement key laboratory and analytical SOPs in the QC lab.

• Maintain HPLC/UPLC instrumentation as well as perform preventative maintenance on analytical equipment, as needed.

• Draft technical reports (compendial method suitability).

• Be Qualified Trainer on HPLC/UPLC analytical method.

• Draft technical protocols and reports (compendial method suitability).

• Perform protein biologic analytical tests to support cGMP batch release including qPCR testing

• Draft technical protocols and associated reports (method qualification, development).

• Independently support analytical method qualific