Biologics Process Development Manufacturing Associate II

Job Summary

This position is a full-time, senior level position at the Gates Biomanufacturing Facility located on the CU Anschutz campus and serves on the Biologics team. The role will be responsible for supporting biologics‑based therapeutics manufacturing activities, including Process Development (PD) and Process Engineering (PE), to develop, scale‑up, and transfer new products to cGMP manufacturing.

• 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.

Onsite – this role is expected to work onsite.

• 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

• Bachelor's degree in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology, or related field.
• A combination of education and related technical/military/paraprofessional experience may be substituted for the bachelor's degree on a year‑for‑year basis.
• 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.

Applicants must meet minimum qualifications at the time of hire.

• 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.

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 that cross shifts. While not typical, this irregularity of work hours should be expected.

Must be willing and able to lift up to 50 lbs. of lab equipment with assistance.

• 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.
• Significant lab, process development and/or manufacturing experience.