Professional Research Assistant
University of Colorado - School of Medicine
Professional Research Assistant
Nature of Work:
The selected candidate will be responsible for performing cell processing and testing at the newly established Gates Biomanufacturing Facility to meet client and cGMP requirements for the manufacture, testing, and distribution of cell-based products for patient administration.
This position requires experience related to performing aseptic cell culture.
This position reports directly to the Director of Cell Therapies at the Gates Biomanufacturing Facility.
Examples of Work Performed:
- Full-time position at the Gates Biomanufacturing Facility located nearby the University of Colorado Anschutz Medical Campus.
- Development and implementation of startup operations and SOPs at the new facility to meet client and cGMP requirements for cell-based products.
- Perform aseptic cell culture processing on a routine basis.
- Develop and implement SOPs for cell therapy manufacturing and laboratory operations.
- Perform cell characterization and cell-based assays on a routine basis using techniques such as flow cytometry, quantitative real-time PCR, immunostaining, fluorescence cell imaging, ELISA, and fluorescence/luminescence microplate-based assays.
- Development and implementation of process development screening and optimization experiments of cell-based products.
- Develop and implement new analytical test methods for characterization testing of cell-based products.
- Analyze samples and interpret results. Perform calculations and statistical analysis to complete research test results.
- Maintain laboratory notebooks, logs, and computer databases.
- Compile information and results into meaningful formats to ensure content is appropriately represented. This may involve presenting the information to clients.
- Manage, 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.
- Perform calibration, verification, and qualification of equipment, processes, and test methods.
- Manage projects and tasks to meet project expectations related to timelines, budget, and quality.
- Implement continual quality and process improvement processes within the development and manufacturing phases of a product.
- Long-term, train new staff in cell therapy processes to achieve operational, schedule, and quality requirements.
- Long-term, employee could develop laboratory techniques related to the development, manufacturing, and analytical testing of therapeutic proteins produced at this facility.
- Provide exceptional customer service to users of the facility.
- Work in a professional and collaborative manner with coworkers and prospective users.
Knowledge, Skills, and Abilities:
- Experience performing aseptic cell culture.
- Experience working in a start-up environment with a track record of being a team-oriented, self-starter capable of operating independently.
- Experience operating and maintaining cell/tissue culture and analytical equipment.
- Experience isolating and establishing cell lines from tissues.
- Experience with flow cytometry, qRT-PCR, ELISA, cell-based assays, ELISAs, fluorescence/luminescence microplate assays, cell viability assays, and fluorescence microscopy.
- Experience with managing databases.
- Knowledge of statistical analyses and using R scripting programming.
- Experience with creating risk assessments and developing preventive measures.
- Experience with image analysis software.
Infectious Materials/Human Blood or Bodily Fluids
Radioactive Materials/Ionizing Radiation
HIPAA - Access to PHI
HIPAA - Operations
HIPAA - Payment
HIPAA - Research
HIPAA - Treatment
- Bachelor's Degree or equivalent experience in Cell Biology, Bioengineering, Chemical Engineering, or related field.
- At least 1 year of experience related to general tissue/cell culture.
- At least 2 years of experience performing research in an academic setting.
- Master's Degree or equivalent experience in Cell Biology, Bioengineering, Chemical Engineering, or related field.
- At least 1 year of experience specifically related to performing aseptic cell culture for a variety of human-derived cell populations.
- Experience working in a cGMP manufacturing setting related to biological drugs intended for human use.
- Experience working with FDA and ISO regulations.
- Experience writing applications for IRB approval.
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 University of Colorado strongly supports the principle of diversity. 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.
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.
Special Instructions to Applicants:
Questions should be directed to Thomas Payne at firstname.lastname@example.org.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 09374
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 do not submit any of your application material (via email) to the job posting contact.
APPLICATION DEADLINE: Review of applications will begin immediately and will continue until the position is filled.
Job Category: Faculty
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20143 - SOM-Dermatology
Posting Date: May 2, 2017
Closing Date: Ongoing
Posting Contact Name: Bobbi House
Posting Contact Email: email@example.com
Position Number: 00629913