General Information:
University of Colorado’s School of Medicine
Position: Director of Quality
About the Company:
The Gates Biomanufacturing Facility will be established as an auxiliary service center of the University of Colorado’s School of Medicine, Department of Dermatology and the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology
Job Description:
- The Gates Biomanufacturing Facility is seeking a qualified candidate that will be responsible for directing quality assurance and quality control (QA/QC) for the Facility.
- The Director of Quality will plan and establish QA/QC policies, programs, systems and initiatives.
- In addition, the selected candidate will establish testing methods and systems to ensure quality standards and specifications are met.
Requirements:
- Examples of Work Performed
- Design, establish, and manage QA/QC policies, programs and systems.
- Review and approval of all products and materials for release.
- Participate in the preparation of CMC section for a biological product IND.
- Establish positive relationships with internal and external members of the Gates Center community as well as users of the manufacturing facility.
- Knowledge, Skills, and Abilities
- Master’s Degree or equivalent experience in a life sciences discipline.
- Significant industrial experience in QA/QC.
- Strong knowledge of cGMP/cGTP regulations and industry standards.
- Familiar with the preparation and development of CMC section for a biological product IND.
- Experience with working in a biotech startup environment.
- A team-oriented, self-starter capable of operating independently.
- Effective interpersonal communication skills.
- Minimum Requirements
- Master’s Degree or equivalent experience in a life sciences discipline.
- At least 10 years of industrial biotech experience in a QA/QC role.
- A team-oriented, self-starter capable of operating independently.
- Preferred Qualifications
- Experience working for biotech companies is a plus.
- Experience working in a cGMP manufacturing setting is desired.
- Application Information:
- All applications must be submitted electronically at www.jobsatcu.com, refer to job posting RF01234.
- The jobsatcu.com employment board has this position listed as a Research Instructor.
Required Application Materials:
- When applying at www.jobsatcu.com, applicants must include:
- A letter of application which specifically addresses the job requirements and outlines qualifications.
- A current CV/Resume.
- The names, addresses, daytime telephone numbers and e-mail addresses for three professional references.
More information
- Review of applications will continue until the position is filled.
- 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 http://www.cu.edu/pbs/
- Please be advised that the University does check references as part of the employment process.
