Professional Research Assistant - cGMP Manufacturing Assoc II
- Employer
- University of Colorado Anschutz Medical Campus
- Location
- Denver, CO
View more
- Administrative Jobs
- Academic Affairs, Research Staff & Technicians
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
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Description
Qualifications
Minimum Requirements:
Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jul 29, 2021
Unposting Date: Ongoing
UNIVERSITY OF COLORADO DENVER | ANSCHUTZ MEDICAL CAMPUS
Gates Biomanufacturing Facility
Research Assistant, cGMP Manufacturing Associate II – Cell Therapy
Position Number: 00785982
The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at: Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2 Denver: https://www.ucdenver.edu/coronavirus Exemptions vary by campus location/department. Campus/Unit-Specific Exemptions:
- Anschutz Campus – Exemptions are allowed for medical or religious reasons.
- Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.
- Consolidated/Central Services Administration – Will follow Anschutz policy on exemptions.
The University of Colorado Denver 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
Nature of Work:The University of Colorado seeks a cGMP Cell Therapy Manufacturing Associate to work in the Gates Biomanufacturing Facility located near the Anschutz Medical Campus in Aurora. The GBF is an academic mission-based cGMP contract manufacturing facility dedicated to the development and manufacture of novel biological therapies for human clinical trials. The selected candidate will be responsible for implementing operations, maintaining the cGMP facility, and properly executing procedures at the Gates Biomanufacturing Facility to meet client and cGMP requirements. The University of Colorado 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. Professional Field:This position requires experience related to general biology/chemistry laboratory techniques and performing aseptic cell culture manipulations for a variety of mammalian-derived cell populations.Supervision Received:This position reports directly to the Senior Operations Manager - Cell Therapy at the Gates Biomanufacturing Facility.Supervision Exercised:This position will not have direct reports.Examples of Work Performed:Job Duties and Responsibilities will include, but are not limited to, the following:
- Full-time position at the Gates Biomanufacturing Facility located nearby the University of Colorado Anschutz Medical Campus.
- Implementation of manufacturing operations of cell-based products at the facility, including, but not necessarily limited to: performing all steps in manufacture of products for human clinical trials, preparation of solutions and process intermediates, resolving technical issues, design and/or execution of experimental studies.Perform aseptic cell culture on a routine basis.Perform work inside and outside of clean room environment (ISO 5, 7, and 8).Monitor and maintain processing and testing equipment, facilities, and supplies. This will include routine handling and lifting of laboratory supplies, and bench-top equipment and regular cleaning of facility, supplies, and equipment.Document manufacturing operations using Good Documentation Practices, including writing reports, deviations, qualifications, change controls, etc.
- Work collaboratively as needed on Process Development projectsMaintain laboratory notebooks, GMP documents, logs, and computer databases.
- Manage tasks to meet project expectations related to timelines, budget, and quality.
- Provide exceptional customer service to users of the facility.
- Work in a professional and collaborative manner with coworkers and current and prospective collaborators.Includes the opportunity to become a trainer, subject matter expert, and/or process lead in one or more technical areas.
Qualifications
Minimum Requirements:
- Masters Degree or equivalent work experience in Microbiology, Cell Biology, Bioengineering, Chemistry, Chemical Engineering, Molecular Biology, or related field; Or Equivalent experience in the field.
- General laboratory biochemistry or related experience.
- Experience with aseptic cell isolation, expansion, manipulation, and/or cryopreservation techniques.
- At least 2 years of experience related to cell-based therapeutics is preferred.
- Basic understanding of Good Manufacturing Practice (GMP).
- Basic understanding of cleanroom (ISO 8 minimum) and related technical principles.
- Ability to accommodate a flexible manufacturing schedule.
Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Jul 29, 2021
Unposting Date: Ongoing
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