University of Colorado Senior Scientist - Process Development in Aurora, Colorado
University of Colorado – School of Medicine
Sr. Professional Research Assistant or Research Associate
Working Title: Senior Scientist – Process Development
School of Medicine – Gates Biomanufacturing Facility
Position # 00050225
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 Gates Biomanufacturing Facility (GBF) is a Contract Development and Manufacturing Organization (CDMO) that serves academic and biotech startups seeking to reach clinical trials. The GBF is located on the University of Colorado – Anschutz Medical Campus and is seeking an experienced Senior Scientist for the process development team. As a part of the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology, GBF serves the University of Colorado School of Medicine, UCHealth and Children’s Hospital of Colorado as well as industry-based partners. The Gates Biomanufacturing Facility is dedicated to the development and manufacture of novel biological and cell/gene therapies to support novel early phase human clinical trials for a variety of therapies and applications.
The Senior Scientist will work with clients and investigators to lead process and/or analytical development related to therapeutic protein manufacturing. This is an open rank recruitment that will be filled at the Sr. Professional Research Assistant or Research Associate level depending on the educational and experience level of the selected candidate.
Examples of Work Performed :
Work with clients and investigators for tech-transfer and development of protein manufacturing processes including experimental design, data analysis and interpretation
Author and Review Development and Production Reports and CMC sections of INDs
Serve as a technical lead for scale-up of protein manufacturing processes to the cGMP suites
Lead analytical method development for in-process, release and characterization assays
Lead technical teams to meet project expectations related to timelines, budget, and quality
Provide exceptional communication and customer service to users of the facility
Work in a professional and collaborative manner with coworkers and prospective user
Design of experiment (DOE), interpretation of complex data sets and presentation of results
Protein process and/or product development expertise in upstream, downstream and/or formulation
Protein process and analytical method technical transfer
Protein process scale-up for multiple unit operations such as fermentation, mixing, filtration (depth, membrane and tangential flow/ultrafiltration), centrifugation and/or chromatography
Criticality and risk analysis methods such as FMEA, CQA and CPP assessments
Familiarity with regulatory requirements for CMC sections of Phase 1 INDs and cGMP manufacturing guidance
Protein biophysical characterization (AUC, HPLC, Mass Spec, DSC, DLS, ELISA, UV, CD, IR etc) and analytical method development, verification and/or qualification
Strong understanding of protein solubility, stability, aggregation and folding/refolding
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 at http://www.cu.edu/employee-services .
University of Colorado Denver | 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 checks for all new employees prior to their employment.
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.
Benefits: https://www.cu.edu/employee-services/benefits .
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.
Degree in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology, Pharmaceutical Science or other relevant field
Bachelor’s with a minimum of 8 years relevant experience
Master’s with a minimum of 5 years relevant experience
PhD with a minimum of 2 years relevant experience
Significant protein-related process, formulation and/or analytical method development experience
Preferred Qualifications :
PhD and 5 years of experience in protein process and/or analytical development
Pharmaceutical development and/or Contract Development and Manufacturing Organization (CDMO) experience
Subject matter expert in multiple protein process, formulation and/or analytical development areas
E. coli based protein process development, including fermentation, refolding and chromatography
Knowledge, Skills & Abilities/Competencies :
Excellent written and oral communication skills
A team-oriented, self-starter capable of operating independently
Primary Location: Aurora
Job Category Faculty
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Oct 28, 2019
Unposting Date Ongoing
Posting Contact Name Branden Salinas
Posting Contact Email branden.Salinas@cuanschutz.edu
Posting Number 00050225
Req ID: 17622
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.