DescriptionUniversity of Colorado Denver l Anschutz Medical CampusCharles C. Gates Center for Regenerative Medicine and Stem Cell BiologyGates Biomanufacturing FacilityWorking Title: Director of Protein Development and ManufacturingOffiical Title: Research InstructorPosition #00689259 – Requisition 19233
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 University of Colorado Denver | Anschutz Medical Campus is a comprehensive urban research university serving more than 28,000 students in metropolitan Denver and online. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado public institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer 119 highly rated degree programs through 13 schools and colleges. The University of Colorado Denver | Anschutz Medical Campus is well known for its distinctive and highly productive research programs, its world-class health facilities at the Anschutz Medical Campus and its well-established partnerships in business, industry and government. These campuses currently have over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at our Anschutz Medical Campus, a significant number of undergraduate and graduate degree programs are taught at our comprehensive campus in the heart of downtown Denver. Denver is one of America’s most vibrant urban centers and the downtown campus, located just steps from the Denver Center for Performing Arts and the LoDo District, affords our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets. The Charles C. Gates Center for Regenerative Medicine has an opening for a full-time Research Instructor faculty position at the Gates Biomanufacturing Facility. The Gates Biomanufacturing Facility, established in 2014, is an academic cGMP manufacturing facility dedicated to the development and manufacture of novel biological therapies for early phase human clinical trials. The GBF team works with researchers and companies, both internal and external to the University, interested in translating laboratory discoveries into protein and cell therapy products for first-in-human clinical trials. This position will be responsible for directing process development and manufacturing operations related to protein-based therapeutics at the Gates Biomanufacturing Facility. The University of Colorado Denver seeks a Director of Protein Development and Manufacturing to work in the Gates Biomanufacturing on the Anschutz Medical Campus in Aurora. The University of Colorado 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. The university has proudly positioned itself as one of the top urban research universities in the country. Job Responsibilities:
- Full time position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus.
- Continued development and management of established protein processes, manufacturing operations and SOPs at the facility.
- Overall technical responsibility for project execution and quality including relevant CMC IND sections.
- Design, manage and implement both upstream and downstream manufacturing processes to meet user and cGMP requirements.
- Guide tech transfer as well as the development and scale up of bioprocesses for internal and external user’s products.
- Design and establish analytical test methods for product characterization.
- Staff management with >5 reports, hiring and resource planning.
- Supervise and support the development of staff members.
- Contribute to Business Development thru client identification, education and recruitment.
- Participate in the preparation of proposals and Statements of Work for prospective users of the facility.
- Significant contributor to facility strategy and university relations.
- Develop and communicate staff Roles and Responsibilities, and coordinates across projects and functions.
- Actively collaborate with the facility Executive Director and other facility discipline Directors (Cell Therapy, Quality, Supply Chain/Project Management, Medical).
- Set and deliver department strategy and goals.
- High-level technical and project guidance.
- Client relations including conflict resolution.
- Quality Council representative for department.
- Direct capital projects and planning.
- Provide exceptional communication and customer service to users of the facility.
- Work in a professional and collaborative manner with coworkers and prospective users.
- Oversee and maintain protein process equipment and supplies.
- Master’s Degree or equivalent experience in Chemical Engineering, or related field.
- At least 5 years of industrial biotech experience related to process development, scale up, or manufacturing of therapeutic proteins.
- Experience operating protein manufacturing equipment.
- A team-oriented, self-starter capable of operating independently in a start-up environment.
- Experience with management and supervising technical staff.
- PhD or equivalent experience in Chemical Engineering, or related field.
- Experience working in a cGMP manufacturing setting related to biological drugs intended for human use.
- Aptitude for technical sales and business development.
- Experience preparing CMC sections of an IND.
- Experience supervising technical staff.
Job Category: Faculty
Primary Location: Aurora
Posting Date: Sep 18, 2020
Unposting Date: Ongoing