Biologics Process Development Manufacturing Associate II

Key Responsibilities

• 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.
• Adequately adhere 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.

Qualifications

• Bachelor’s degree in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology or related field.
• Minimum of 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.

Why Join Us

The opportunity offered by the Gates Biomanufacturing Facility (GBF) is one of a kind. They 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. The GBF and its partners on the CU Anschutz campus are delivering lifesaving therapies and work to develop more every day. They are only limited by their resources and need you to make their journey a success!

Why work for the University?

• Excellent benefits package including medical, dental, disability, life, vision, retirement, paid time off, and tuition benefits.
• Reduced rate RTD Bus and light rail service.
• Many additional perks & programs with the CU Advantage.

Condition of Employment

• This is a full-time onsite position, which may require weekend work and work outside of normal work hours to accommodate the completion of time sensitive critical processes which cross shifts.
• Must be willing and able to lift up to 50 lbs. of lab equipment with assistance.

Competencies/Knowledge, Skills & Abilities

• Knowledge of spray drying processes and powder product handling, including operation of spray drying equipment, control of critical process parameters, and proper handling, storage, and transfer of dry powder formulation.
• Knowledge of mRNA production and LNP handling, including in vitro transcription, chemical synthesis, RNA purification, LNP formulation, and basic understanding of process equipment and quality considerations.
• 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.