Process Development and Manufacturing Associate III

University of Colorado Anschutz Medical Campus

Department: Gates Institute Biomanufacturing Facility

Job Title: Process Development and Manufacturing Associate III

Position #:00837329 – Requisition #:37316

Job Summary:

This position is a full-time, subject matter expert position at the Gates Institute and Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Biologics team. The Process Development and Manufacturing Associate III is responsible for supporting the manufacturing of biologics-based therapeutics and participating in all cross functional activities including but not limited to Process Development (PD) and Process Engineering (PE) to develop, scale-up, and transfer new products to cGMP manufacturing.

Key Responsibilities:

This role will have the following responsibilities including but not limited to the following:

• Significant independent contribution to:
• • Tech-transfer of (E. coli produces recombinant protein) processes from client to development to manufacturing.
  • Scale-up of multiple biologics manufacturing processes for the cGMP suites.
  • Capital, facility, and equipment upgrades and projects.
  • Identify and/or confirm required materials for manufacturing processes.
  • Plan manufacturing operations, set up the schedule and ensure to meet due dates for key deliverables.
• Independently support process development and manufacturing activities for multiple unit operations, including E.coli fermentations, cell lysis and inclusion body preparation, purification by liquid chromatography and alternate methods, chemical refolding as well as formulation development by tangential flow filtration. Includes the operation of Sartorius Biostat Fermenters (5 – 50 L scale), Sartorius TFF systems (Slice and Sartoflow).
• Lead analytical assay development; HPLC/UPLC, DSL, and gel electrophoresis.
• Author master batch records, production, and tech transfer reports.
• Mentor teams to meet project expectations related to timelines, budget, and quality.
• Provide exceptional communication and customer service to users of the facility.
• Prepare and present technical data and processing information to clients, as necessary.
• Work in a professional and collaborative manner with coworkers and prospective users.
• Perform other duties as assigned by their supervisor to support departmental and organizational goals.

Work Location:

Onsite – this role is expected to work onsite full-time and is located in Aurora, CO.

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus – the University of Colorado – Anschutz Medical Campus.