Biologics Process Development Manufacturing Associate II

Biologics Process Development Manufacturing Associate II

Description

University of Colorado Anschutz

Department: Gates Institute Biomanufacturing Facility

Job Title: Biologics Process Development Manufacturing Associate II

Position #:

The Biologics Process Development Manufacturing Associate II participates in biologics-based therapeutics manufacturing activities, including process development and process engineering to develop, scale-up, and transfer products to cGMP manufacturing. The role is onsite at the Gates Biomanufacturing Facility.

• Execute manufacturing processes for recombinant proteins, nucleic acids, and other biologic therapeutics across development, pilot-scale, and engineering runs under GMP and non-GMP conditions.
• Operate and monitor manufacturing equipment to ensure process consistency and performance.
• Support scale-up activities and engineering runs as required.
• Perform spray drying operations in ISO Class 7 cleanroom and isolator environments.
• Manage dry powder handling, transfer, and containment to ensure product integrity and operator safety.
• Maintain equipment and ensure proper setup and cleaning procedures are followed.
• Ensure adherence to cGMP guidelines, company procedures, and regulatory requirements.
• Promote and maintain a safe working environment in manufacturing and laboratory areas.
• Participate in audits, inspections, and safety initiatives.

Minimum Qualifications:

• Bachelor's degree in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology or related field.
• 2+ years of biologics manufacturing or process engineering experience.
• At least one year's experience working in a cGMP manufacturing setting intended for human use, including work in ISO Class 7 and 8 rooms and ISO Class 5 biosafety cabinets.

Preferred Qualifications:

• Three plus (3+) years biologics manufacturing or process engineering experience.
• Experience with biologics-based manufacturing process.
• Experience operating and maintaining processing equipment.
• Experience with drug product handling and fill-finish operations, including aseptic processing, and operation of fill-finish equipment in compliance with cGMP and sterility assurance requirements.

Onsite

Application Information

Screening of Applications Begins:
July 31, 2026

Anticipated Pay Range: $61,275 - $82,108

The University of Colorado is an Equal Opportunity Employer. We encourage applications from all qualified individuals, including protected veterans and individuals with disabilities. The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process.

This description reflects the job as of the date shown and is subject to change. For full details, refer to the official posting.