Director of Cell Therapy

DescriptionUniversity of Colorado | CU Anschutz Medical CampusGates Center for Regenerative Medicine | Gates Biomanufacturing FacilityDirector of Cell TherapyPosition # 00779025 – Requisition #19257* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *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 Gates Biomanufacturing Facility has an opening for a full-time University Staff (unclassified) Research Services Director position.The University of Colorado – Anschutz Medical Campus is an 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 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 - Anschutz campus is a leading research institution with an emphasis on growing its cellular therapy research and development. This position will translate therapies for leading researchers at the University of Colorado – Anschutz campus. The Gates Center for Regenerative Medicine has an opening for a Director of Cell Therapy at the Gates Biomanufacturing Facility. 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 directing process development and manufacturing operations related to cell-based therapies at the Gates Biomanufacturing Facility. Jobs in this career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.Directors are responsible for the ongoing leadership and oversight of a department, including the Development of strategies and processes which contribute to the University and/or campus mission and accountability for services provided. Directors are responsible and accountable for the analysis of fiscal and human resources required to achieve department objectives including hiring, compensation, termination, and performance management of subordinate employees. Job Responsibilities:

• Lead and develop the technical team in the Cell Processing Department.


• Partners in the business development process to identify prospective client needs, present GBF capabilities and expertism, and prepare initial scopes of work with pricing.


• Provide overall project and Cell Therapy technical guidance


• Guides tech transfer as well as develops processing and control procedures and characterization assays that will be used for the GMP manufacture of prospective products.


• Assist collaborators in the preparation of Investigational New Drug (IND) applications, particularly the Chemistry, Manufacturing and Controls (CMC) section.


• Works closely with Quality team to establish and optimize Standard Operating Procedures (SOPs) for the GMP manufacture of prospective biotherapeutics. Manage production risks and insure that Cell Processing Department adheres to all facility and equipment SOPs.


• Works with the Executive Director and other GBF Directors to implement a coordinated service delivery strategy.


• Provides exceptional customer service to users of the Gates Biomanufacturing Facility.


• Collaborates effectively with multi-disciplinary groups composed of regulatory specialists, clinical research staff, physician investigators and GBF staff. Participates as a member of the GBF Leadership Team, contributing efficaciously to the organization’s direction, policies, processes, and culture.

Salary and Benefits:Salary is negotiable and commensurate with skills and experience. 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/benefitsTotal Compensation Calculator: http://www.cu.edu/node/153125Diversity 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 hr.adacoordinator@ucdenver.edu. 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.The 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 investigations for all prospective employees.

QualificationsMinimum Requirements

• Ph.D. in Bioengineering, Immunology, Molecular Biology, Chemical Engineering or related field


• Minimum of 4 years of postdoctoral and/or industry experience


• Expertise in tissue/cell process optimization, cell isolation and purification, cell expansion and scale-up, tissue/cell preservation and storage culture of cell-based therapeutics.
Minimum of 6 years in a leadership role of a technical team.

Preferred Qualifications

• Strong knowledge of cGMP regulations and experience working in a cGMP manufacturing setting.


• Experience in the preparation of investigational New Drug (IND) applications, and in obtaining FDA approval for INDs.


• Experience with working in a biotech startup environment is preferred.


• Demonstrable expertise in negotiation and client management skills

Job Category: Research Services
Primary Location: Denver
Schedule: Full-time
Posting Date: Sep 22, 2020
Unposting Date: Ongoing