University of Colorado – School of Medicine
Professional Research Assistant
The University of Colorado Denver l Anschutz Medical Campus 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.
The Charles C. Gates Center for Regenerative Medicine has an opening for a full-time Professional Research Assistant at the newly established Gates Biomanufacturing Facility. The Gates Biomanufacturing Facility is an academic cGMP contract manufacturing facility dedicated to the development and manufacture of novel biological therapies for early phase human clinical trials. This position will be responsible for the day to day Quality Control testing at the Gates Biomanufacturing Facility and will be focused on protein and cellular therapy analytical testing.
The University of Colorado Denver seeks a Quality Control Analyst to work in the Gates Biomanufacturing Facility located near the Anschutz Medical Campus in Aurora. The University of Colorado Denver 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. The university has proudly positioned itself as one of the top urban research universities in the country. The Gates Biomanufacturing Facility is one of the core facilities used to differentiate the university in both regenerative medicines as well as traditional biotech streams.
Full time position at the Gates Biomanufacturing Facility located nearby the Anschutz Medical Campus. The 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.
Perform routine analytical testing in a multidisciplinary, multi-accreditation laboratory space in support of analytical development, qualification/verification and release testing of protein biologics and regenerative medicine 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.
Report to the Manager of Quality Control.
This role will have the following responsibilities including but not limited to the following:
SDS-PAGE and Western Blot
General analytical testing (UV-Vis, pH, Osmolality, CBC, and Endotoxin)
Qualification and/or verification of analytical methods
Assist in process development work as needed
Refine and implement key laboratory and analytical SOPs in the QC lab.
Peer review Quality Control analytical data packets.
Perform preventative maintenance on analytical equipment, as needed.
Participate in the resolution and investigations associated with Non-conformance processes (OOS, CAPA and deviations).
Stocking of laboratory supplies, as needed.
Assist in cleaning of laboratory and other spaces.
Assist the Operations group with technical/operational support, as needed.
Knowledge, Skills, and Abilities
Excellent verbal and written communication skills.
Capable of working as an individual or in a team setting.
Motivated self-starter capable of operating in a start-up environment.
Bachelors Degree or equivalent experience in a related life science discipline or other relevant degree.
1+ years of Quality Control experience in a cGMP laboratory setting.
Familiar with 21 CFR 58, 210, 211, 600 and 1271.
Experience in cellular therapy development and/or release testing.
Experience with analytical method development, qualification, verification or validation.
Flow Cytometry experience.
Salary and Benefits:
Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.
The University of Colorado Denver 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.
The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.
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: https://www.cu.edu/employee-services/total-compensation
Diversity and Equity:
Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx
The University of Colorado Denver | 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 and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
Application Materials Required: Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 14696
When applying, applicants must include:
A letter of application which specifically addresses the job requirements and outlines qualifications
A current Resume/CV
The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please be advised that the University does check references as part of the employment process.
Please do not submit any of your application material (via email) to the job posting contact.