Job Summary:

This position is a full-time, open-ranked position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Quality Control team. At the Associate level, this position will be expected to perform beginner to intermediate level tasks such as low complexity analytical procedures and the drafting or editing of related documentation. With varying degrees of independence, this position performs routine analytical testing in a multidisciplinary laboratory space in support of analytical development, qualification, and release testing of protein biologics and regenerative medicine cellular therapies. This position will begin establishing and/or build on their existing knowledge base regarding the analytical methodology that they are routinely performing as well as basic Quality principles such as Good Documentation Practices (GDP) as well as Good Manufacturing Practices (GMP).

At the Analyst 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). Positions at the QC Analyst II level will act as a subject matter expert for the Quality Control team in one or more analytical methodologies.

This position will be required to understand and implement principles of aseptic technique in the laboratory and GMP clean suites. All work will be completed within a GMP (21 CFR Part 210/211) Quality Control laboratory. This position will not support any academic research.

Key Responsibilities:

Entry Level - QC Associate I:

• Generate, submit, and analyze environmental monitoring samples from the GMP manufacturing clean suites on a weekly basis.
• Perform protein biologic analytical tests to support cGMP batch release (DLS, pH, and UV-Vis spectrophotometry).
• Perform microbiological analytical tests to support cGMP batch release (Bioburden, Endotoxin, and Gram Stain).
• Perform regenerative medicine cellular therapy analytical tests to support cGMP batch release (Thawing and Cell Counting).
• Perform compendial method suitability testing.
• Analyze new lots of incoming media for growth promotion.

Intermediate Level - QC Associate II: In addition to the responsibilities, above a position at this level will...

• Generate, submit, and analyze utilities samples on a routine basis.
• Perform additional protein biologic analytical tests to support cGMP batch release (ELISA, and SDS-PAGE).
• Perform additional microbiological analytical tests to support cGMP batch release (Mycoplasma)
• Support method development activities.
• Check in incoming Quality Control samples, maintain an orderly sample submission area, maintain the LabKey sample software, and ship Quality Control samples to third-party laboratories.

Intermediate Level - QC Associate III: In addition to the responsibilities above, a position at this level will...

• Perform additional protein biologic analytical tests to support cGMP batch release (qPCR).
• Draft technical protocols (compendial method suitability).
• Independently support method development activities.
• Draft technical protocols and reports (Environmental Monitoring and Utilities).

Senior Level - QC Analyst I: In addition to the responsibilities, above a position at this level will...

• Generate, submit, and analyze Utilities samples on a routine basis.
• Perform microbiological analytical tests to support cGMP batch release (Mycoplasma).
• Perform additional protein biologic analytical tests to support cGMP batch release (ELISA, and SDS-PAGE).
• Perform additional microbiological analytical tests to support cGMP batch release (Mycoplasma)
• Support method development activities.
• Check incoming Quality Control samples, maintain an orderly sample submission area, maintain the LabKey sample software, and ship Quality Control samples to third-party laboratories.

Principal Level - QC Analyst II - SME Analytical Development: In addition to the responsibilities, above a position at this level will...

• Lead analytical method development activities.
• Mentor other Associates and Analysts on analytical method development.
• Draft development reports.
• Lead analytical method qualification efforts.
• Draft qualification summary reports.

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. They 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. They are only limited by their resources and need you to make their 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.

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.

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

QC Associate I Level:

• A bachelor's degree in related life science discipline or equivalent experience or a directly related field from an accredited institution.
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

QC Associate II Level:

• Bachelor's 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 bachelor's degree on a year for year basis, but not for the specific years of experience.
• 1+ years of Quality Control experience in a cGMP laboratory setting.

QC Associate III Level:

• Bachelor's 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 bachelor's degree on a year for year basis, but not for the specific years of experience.
• 2+ years of Quality Control experience in a cGMP laboratory setting.

QC Analyst I:

• Bachelor's 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 bachelor's degree on a year for year basis.
• 3+ years of Quality Control experience in a cGMP laboratory setting.
• Experience with analytical Flow Cytometry or qPCR.

QC Analyst II:

• Bachelor's 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 bachelor's degree on a year for year basis.
• 5+ years of Quality Control experience in a cGMP laboratory setting.

For All Levels - Applicants must meet minimum qualifications at the time of hire.

Condition of Employment (All Levels):

• This position may require weekend work and work outside of normal business 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.

Preferred Qualifications:

Associate Level I-III Preferred Qualifications:

• 1+ years of Quality Control experience in a cGMP laboratory setting.
• Experience working with 21 CFR 58, 210, 211, 600 and 1271.
• Experience working in a pharma/biotech startup environment.
• Quality system building experience.

QC Analyst I: In addition to the Preferred Qualifications above...

• Experience with analytical method development, qualification, or verification.

QC Analyst II: In addition to the Preferred Qualifications above...

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

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: Chris Freedman christopher.freedman@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by June 7, 2024.

Anticipated Pay Range:

The starting hiring ranges for this position has been established as:

Quality Control Associate I-III: $48,119 - $61,208

Quality Control Analyst I: $59,701 - $75,940

Quality Control Associate: $73,747 - $93,806

The above hiring ranges represent the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position may be eligible for overtime compensation, depending on the level.

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

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.

The University of Colorado seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.