Process Development and Manufacturing Associate III
Description
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:
Key Responsibilities:
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
Why Join Us:
delivering to patients
Why work for the University?
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
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
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:
Screening of Applications Begins:
Anticipated Pay Range:
Equal Employment Opportunity Statement:
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
Primary Location
Schedule
Posting Date
Unposting Date
To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=37316&lang=en (https://apptrkr.com/6393006)
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Process Development and Manufacturing Associate III - 37316 University Staff
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. This role will have the following responsibilities including but not limited to the following:
this role is expected to work onsite full-time and is located in Aurora, CO.
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 .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 (https://apptrkr.com/get\redirect.php?id=6393006&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including: There are many additional perks & programs with the CU Advantage (https://apptrkr.com/get\redirect.php?id=6393006&targetURL=https://advantage.cu.edu/) .
Applicants must meet minimum qualifications at the time of hire.
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 position2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: Dash Batt, dash.batt@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=6393006&targetURL=dash.batt@cuanschutz.edu)
Screening begins on July 31, 2025
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 (https://apptrkr.com/get_redirect.php?id=6393006&targetURL=http://www.cu.edu/node/153125)
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.
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 (https://apptrkr.com/get_redirect.php?id=6393006&targetURL=hr.adacoordinator@cuanschutz.edu) .
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.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get\redirect.php?id=6393006&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . 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 (https://apptrkr.com/get\redirect.php?id=6393006&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 21796 - ADM CHAN GBF Spnsrd/Gift : Full-time : Jul 17, 2025 : Aug 1, 2025, 5:59:00 AM Posting Contact Name: Dash Batt Posting Contact Email: dash.batt@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=6393006&targetURL=dash.batt@cuanschutz.edu) Position Number: 00837329jeid-9393aa3d11f68742b5a2c281ab28bc74
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.
