Professional Research Assistant
Manufacturing Associate II/III
Working Title: Professional Research Assistant - Biologics Development and Manufacturing
Gates Biomanufacturing FacilityThe Charles C. Gates Center for Regenerative Medicine has an opening for a full-time Manufacturing Associate II (or III) at the Gates Biomanufacturing Facility. The Gates Biomanufacturing Facility is an academic cGMP facility dedicated to the development and manufacture of novel cell-therapy and protein-based therapies for early phase human clinical trials. This position will be responsible for developing, scaling-up, and implementing purification processes related to biologics-based therapeutics.
The University of Colorado Denver is an urban research university serving more than 28,000 students in metropolitan Denver and online. The university has proudly positioned itself as one of the top urban research universities in the country. As part of this commitment to excellence the Anschutz campus has invested in the capability to development and manufacture materials for clinical trials in cGMP Phase 1 compliant manner.Job Summary
The Manufacturing Associate II (or III) is responsible for supporting manufacturing of biologics based therapeutics and participating all cross functional activities including but not limited to Process Development (PD) and Process Engineering (PE) to develop, scale-up, and transfer new products to cGMP manufacturing.Job Responsibilities
Full-time position at the Gates Biomanufacturing Facility located at the University of Colorado Anschutz Medical CampusExecute recombinant protein manufacturing processes at development, pilot scales and engineering run including buffer, media and solution preparation, fermentation, cell lysis, chromatography and ultrafiltration. Execute analytical methods for protein characterization including UV-Vis spectroscopy, SDS-PAGE and HPLC.Execute molecular biology techniques related to DNA plasmid production, nucleic acid modification, and in vitro transcription. Perform analysis of nucleic acid by gel electrophoresis, qPCR and HPLC.
Performs manufacturing activities according to cGMP guidelines, including batch record execution line clearanceEnsures safety and cGMP compliance in the manufacturing area.Develop and author necessarily supporting cGMP documentation that supports all manufacturing processes and operations, including but not limited to: Equipment Use Logs, Standard Operating Procedures (SOPs), Batch Production Records, Receiving Inspections, Deviation Reports.Troubleshoot process and/or product failures and investigate deviation. Drive CAPA investigations and implementation of actions working closely with the Quality Assurance.Communicate with other departments and cross functional teams to ensure for successful execution of operations for cGMP manufacturing and ensure that equipment and materials are available for production runs.Prepare and present technical data and processing information to clients, as necessary.Oversee and coordinate teams to meet project expectations related to timelines, budget, and quality.Train and mentor new employees, junior scientists and interns.Provide exceptional customer service to users of the facility and work in a professional and collaborative manner with coworkers and external clients.Salary and Benefits:
The hiring salary is $46,000-$76,000 and is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training. The above salary range (or hiring range
) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at 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: https://www1.ucdenver.edu/offices/human-resources/employee-relations-performance/ada-compliance
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.
Bachelor Degree in Biochemistry, Biology Bioengineering, Chemical Engineering, Chemistry or equivalentManufacturing experience
Applicants must meet minimum qualifications at the time of hire. Preferred Qualifications
Experience with biologics based manufacturing processExperience with authoring Standard Operating Procedures (SOPs), Batch Production Records, Raw Material Specifications, Deviation Reports Experience with inclusion body based solubilization, refolding, and purification techniquesExperience working in a cGMP manufacturing setting intended for human use, including work in ISO Class 7 and 8 rooms and ISO Class 5 biosafety cabinets Experience operating and maintaining processing equipmentJob Category:
Jun 1, 2021Unposting Date:
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