Description

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
Position number:00773467

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 interpretationTechnical lead in the transfer of projects into the facility and from process development to manufacturing scaleCoordinates resources and executes tech transfer and scale-up plans with technical leads and/or project managersSubject 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 reviewAuthor sections of Development and Production Reports and CMC sections of INDsPossible 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 planningMentor teams to meet project expectations related to timelines, budget, and qualityProvide exceptional communication and customer service to clients of the facilityWork 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.

 

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.

 

QualificationsRequired Qualifications: 

Master’s Degree (in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology)Minimum 5 years’ relevant experience or equivalentExcellent 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 areaE. coli based protein process development, including fermentation, refolding, chromatography, tangential flow filtrationOperation 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

Mentoring experienceOperations planning, lab management , project management, and/or team leadership experienceKnowledge, 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

Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Nov 16, 2020
Unposting Date: Ongoing