Director of Cell Therapy – HigherEdJobs

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Description

University of Colorado | CU Anschutz Medical Campus

Gates
Center for Regenerative Medicine | Gates Biomanufacturing Facility

Director of Cell Therapy

Position # 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/benefits

Total Compensation Calculator: http://www.cu.edu/node/153125

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 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.

Qualifications

Minimum Re
q uirements

  • 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

Special
Instructions to Applicants : Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin immediately, and will
continue until the position is filled. Application Materials Required : Cover Letter, Resume/CV, List of References Application Materials
Instructions : Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements
and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting
both on and off-list references)

Job Category: Research Services

Department: U0001
— DENVER & ANSCHUTZ MED CAMPUS – 21796 – SOM-DERM GATES GBF

Posting Date: Sep 22, 2020

Closing Date: Ongoing

Contact Name: Anton Mick

Contact Email: anton.mick@cuanschutz.edu

Posting Number:
00779025

The University of Colorado is committed to diversity and equality in education and employment.

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