University of Colorado Senior Professional Research Assistant in Aurora, Colorado
University of Colorado | CU Anschutz Medical Campus
Gates Center for Regenerative Medicine | Gates Biomanufacturing Facility
Sr. Professional Research Assistant
Operations Lead – Protein Process Development and Manufacturing
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 Center for Regenerative Medicine has an opening for a full-time Operations Lead for the Protein Development and Manufacturing team. The Gates Biomanufacturing Facility is an academic cGMP manufacturing facility dedicated to the development and manufacture of novel biological therapies for early phase human clinical trials. This position will be responsible for leading process development and manufacturing operations related to protein-based therapeutics at the Gates Biomanufacturing Facility. This individual will help design and execute protein production processes in the process development and manufacturing suites for Phase I manufacturing. Responsibilities also include assisting in technical transfer of processes between client and GBF, as well as between process development to GMP manufacturing (50 L fermenter scale).
Job Responsibilities :
Lab and/or manufacturing resource planning, team coordination and execution, including data analysis, summaries and interpretation
Technical lead in the transfer of projects into the facility and from process development to manufacturing scale
Coordinates resources and executes tech transfer and scale-up plans with technical leads and/or project managers
Subject Matter Expert (SME)/Trainer on the majority of development and/or manufacturing operations (including any of the following: E.coli fermentation, protein purification, protein formulation/stability, chemical and/or pressure refolding, tangential flow filtration, and other protein production operations)
PD and/or GMP record drafting and review
Author sections of Development and Production Reports and CMC sections of INDs
Possible project/technical transfer lead including client interaction and task management
Acts as team lead for activities, such as, but not limited to, assigns daily task assignments, provides trouble-shooting support, and facilitates team communications.
Possible responsibility for coordinating equipment maintenance, facility and lab upkeep, upgrades and planning
Mentor teams to meet project expectations related to timelines, budget, and quality
Provide exceptional communication and customer service to clients of the facility
Work in a professional and collaborative manner with coworkers and prospective users
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 .
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Diversity and Equity:
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Office of Equity: https://www1.ucdenver.edu/offices/equity
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.
Master’s Degree (in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology)
Minimum 5 years’ relevant experience or equivalent
Excellent knowledge of GDP, GLP and/or GMP
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications :
Subject matter expert in a process, manufacturing and/or analytical development area
E. coli based protein process development, including fermentation, refolding, chromatography, tangential flow filtration
Operation of Sartorius Biostat Fermenters (5 – 50 L scale), Sartorius TFF systems (Slice and Sartoflow) and/or AKTA Purification Systems (Pure and Pilot)
Analytical method development experience including chromatography and plate-based assays
Operations planning, lab management , project management, and/or team leadership experience
Knowledge, Skills, and Abilities:
Significant lab, process development and/or manufacturing experience
Excellent written and oral communication skills
A team-oriented, self-starter capable of operating independently in a start-up environment
Primary Location: Aurora
Job Category Faculty
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Nov 16, 2020
Unposting Date Ongoing
Posting Contact Name Pameal Doerner Barbour
Posting Contact Email PAMELA.DOERNERBARBOUR@CUANSCHUTZ.EDU
Posting Number 00773467
Req ID: 19577
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.