Process Development and Manufacturing Associate III

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:
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  • 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.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.

In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• 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: 10/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications

• A Bachelor's Degree (in Biology, Bioengineering, Chemical Engineering, or a relevant field).
  
  
  
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.
  
  
  
  
• Three plus (3+) years of protein-related manufacturing or process engineering experience

Applicants must meet minimum qualifications at the time of hire.

Condition of Employment:

• This position may require weekend work and work outside of normal work hours to accommodate the completion of release testing or other critical processes which 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.

Preferred Qualifications

• A Master's Degree (in Biology, Biochemistry, Bioengineering, Chemical Engineering, Chemistry).
• Five plus (5+) years of protein expression and purification process development.
• At least one year of cGMP manufacturing experience.
• Experience in planning biologics-based manufacturing operations.
• Experience with authoring Standard Operating Procedures (SOPs), Batch Production Records, Raw Material Specifications, Deviation Reports.
• Experience with inclusion body based solubilization, refolding, and purification techniques
• 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.
• Experience operating and maintaining processing equipment.

Competencies/Knowledge, Skills & Abilities:

• Excellent knowledge of GDP, GLP and/or GMP
• 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.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Dash Batt, dash.batt@cuanschutz.edu

Screening of Applications Begins:

Screening begins on July 31, 2025

Anticipated Pay Range:

The starting salary range for this position has been established as $72,313 - $91,983.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible overtime compensation.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator: http://www.cu.edu/node/153125

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.