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University of Colorado Senior Professional Research Assistant in Aurora, Colorado

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 interpretation

  • Technical lead in the transfer of projects into the facility and from process development to manufacturing scale

  • Coordinates resources and executes tech transfer and scale-up plans with technical leads and/or project managers

  • Subject 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 review

  • Author sections of Development and Production Reports and CMC sections of INDs

  • Possible 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 planning

  • Mentor teams to meet project expectations related to timelines, budget, and quality

  • Provide exceptional communication and customer service to clients of the facility

  • Work 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 at http://www.cu.edu/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.

Qualifications

Required Qualifications:

  • Master’s Degree (in Biochemistry, Bioengineering, Chemical Engineering, Chemistry, Biology)

  • Minimum 5 years’ relevant experience or equivalent

  • Excellent 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 area

  • E. coli based protein process development, including fermentation, refolding, chromatography, tangential flow filtration

  • Operation 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 experience

  • Operations planning, lab management , project management, and/or team leadership experience

Knowledge, 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: Faculty

Primary Location: Aurora

Job Category Faculty

Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS

Schedule Full-time

Posting Date Nov 16, 2020

Unposting Date Ongoing

Posting Contact Name Pameal Doerner Barbour

Posting Contact Email PAMELA.DOERNERBARBOUR@CUANSCHUTZ.EDU

Posting Number 00773467

Req ID: 19577

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.

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