Process Development and Manufacturing Associate III
Process Development and Manufacturing Associate III
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Job Description
University of Colorado Anschutz Medical Campus
Department:Gates Institute Biomanufacturing Facility
Job Title: Process Development and Manufacturing Associate III
Position #:Requisition #:37316
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:
- 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.
- Tech-transfer of (E. coli produces recombinant protein) processes from client to development to manufacturing.
- Independently support process development and manufacturing activities for multiple unit operations including 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 40000 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: work for the University
We haveAMAZINGbenefits and offerexceptional 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 Bachelors 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 bachelors degree on a year-for-year basis.
- Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelors 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 Masters 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
Screening of Applications Begins:
Screening begins on July 31 2025
Anticipated Pay Range:
The starting salary range for this position has been established as $72313 - $91983.
The above salary range (or hiring range) represents the Universitys 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: 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 .
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 othervaccine 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 theoccupational health medical surveillance program.
Required Experience:
IC
Employment Type
Full-Time
