Professional Research Assistant

Manufacturing Associate (Open Rank)

Working Title: Professional Research Assistant - Biologics Development and Manufacturing

Gates Biomanufacturing Facility

Position 00629913 | Req 23418

* Applications are accepted electronically ONLY atwww.cu.edu/cu-careers *

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

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

• Anschutz Campus – Exemptions are allowed for medical or religious reasons.

The University of Colorado | 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 University of Colorado | Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital  and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu

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 Medical Campus has invested in the capability to development and manufacture materials for clinical trials in cGMP Phase 1 compliant manner.

The Charles C. Gates Center for Regenerative Medicine has an opening for a full-time Manufacturing Associate Lead (Open Rank) at the Gates Biomanufacturing Facility.

Position Summary:

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 and participating all cross functional activities including but not limited to operation and maintenance of clean rooms and planning and executing GxP batch production.

Position Responsibilities:  

• Support recombinant protein manufacturing processes at development, pilot scales and engineering run including buffer, media and solution preparation, fermentation, cell lysis, and ultrafiltration.
•  Performs manufacturing activities according to cGMP guidelines, including batch record execution of line clearance
• Ensures 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 salary range (or hiring range) for this position has been established at $48,000 to $80,000.

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:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected] ​.

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.

Minimum Qualifications:

•  Bachelor’s Degree in Applied Science or equivalent
• At least one year of laboratory experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Experience 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 cGMP batch record, Standard Operating Procedures, and Line Clearance
• Experience with authoring Standard Operating Procedures (SOPs), Batch Production Records, Raw Material Specifications, Deviation Reports Operation of fermenter

Competencies:

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Excellent written and oral communication skills
• A team-oriented, self-starter capable of operating independently in a start-up environment