Quality Control Analyst II HPLC

University of Colorado Anschutz Medical Campus

Department:Gates Biomanufacturing Facility

Job Title:Quality Control Analyst II - HPLC

Position #: Requisition #:37816

Job Summary:

This position is a full-time subject matter expert-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Quality Control team. At the Analyst II level position will perform independent routine analytical testing in a multidisciplinary laboratory space with a specific emphasis on analytical development. This position will also support analytical method qualification as well as release testing of protein biologics and regenerative medicine cellular therapies. This position will be expected to have a sufficient knowledge base regarding the analytical methodologies that they are routinely performing as well as basic Quality principes such as Good Documentation Practices (GDP) as well as Good Manufacturing Practices (GMP).

This role will act as a HPLC subject matter expert and will perform specialized testing and assay development for the Quality Control team. This position will focus on assay development and qualification apart from routine analytical testing in a multidisciplinary laboratory space in support of release testing of protein biologics and regenerative medicine cellular therapies. All work will be completed within a GMP (21 CFR Part 210/211) Quality Control laboratory. This position may support method development. This position will NOT support any academic research.

Key Responsibilities:

• Lead HPLC/UPLC and other methodology analytical method development and qualification efforts

• Perform protein biologic analytical tests to support cGMP batch release including HPLC/UPLC DLS pH and UV-Vis spectrophotometry ELISA SDS-PAGE Bioburden Conductivity Endotoxin and Total Organic Carbon (TOC).

• Perform regenerative medicine cellular therapy analytical tests to support cGMP batch release including Product thawing Cell Counting Endotoxin and Gram Stain.

• Perform additional regenerative medicine cellular therapy analytical tests to support cGMP batch release (Mycoplasma Vector Copy Number and Replication Competent Lentivirus qPCR analyses).

• Support in-process HPLC/UPLC testing to support Biologics process development.

• Perform compendial method suitability testing.

• Maintain Qualified Trainer status on three or more analytical methods.

• Maintain Subject Matter Expert in one or more analytical methodology.

• Establish control charts and other metrics for the monitoring and improvement of QC analytical methods

• Refine and implement key laboratory and analytical SOPs in the QC lab.

• Maintain HPLC/UPLC instrumentation as well as perform preventative maintenance on analytical equipment as needed.

• Draft technical reports (compendial method suitability).

• Be Qualified Trainer on HPLC/UPLC analytical method.

• Draft technical protocols and reports (compendial method suitability).

• Perform protein biologic analytical tests to support cGMP batch release including qPCR testing

• Draft technical protocols and associated reports (method qualification development).

• Independently support analytical method qualification activities

Work Location:

Onsite this role is expected to work onsite 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.

Why 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:

• Bachelors degree or equivalent experience in a related life science discipline or other relevant degree. Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelors degree on a year-for-year basis.

• 5 years of Quality Control experience in a cGMP laboratory setting.

• 5 years of Quality Control experience running HPLC assay.

* Experience can be gained simultaneously. Applicants must meet minimum qualifications at the time of hire.

Condition of Employment:

• This position may require weekend work and work outside of normal business hours to accommodate the completion of release testing or other critical processes. While not typical this irregularity of work hours should be expected.

Preferred Qualifications:

• Masters degree in Analytical Chemistry or Pharmaceutical Sciences

• 8 years of Quality Control experience.

• 5 years of experience running HPLC assay method development and qualification.

• Experience in method training (i.e. train the trainer).

• Experience working in a pharma/biotech startup environment.

• Previous experience working with novel protein biologics.

Competencies/Knowledge Skills & Abilities:

• 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: Chandresh Undhad

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration apply by October 8 2025.

Anticipated Pay Range:

The starting salary range for this position has been established as $73747 - $96806.

The above salary 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 for 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 addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.