CMC Operations Manager
CMC Operations Manager
Job Number: 88123
The Center for Cancer Cell Therapy (CCT) is offering an exciting new professional opportunity: CMC Operations Manager (ASA2); a role specifically created to support operational logistics of Process Development and GMP Manufacturing for CCT, to help develop innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients.
This position offers the opportunity to be involved in a team-based approach to providing CMC operational support to the CCT process development and manufacturing team, to develop and implement leading-edge cell and gene-based therapies for Phase I and II clinical trials. This person will be directly involved in managing relationships and will serve as the liaison between multiple groups, to ensure efficient communications and processes.
The CMC Operations Manager reports to the Associate Director of Process Development & Manufacturing, CCT and plays a critical role in developing the CMC Operations Infrastucture, and managing relationships with internal and external CMOs. They may also contribute to New Drug (IND) submissions to the IND and in creating policies and procedures to ensure compliance with US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211); Human Cells, Tissues, and Cellular and Tissue-based Products (21 CFR Part 1271); and Biologics (21 CFR 600) regulations.
The Center for Cancer Cell Therapy is a part of the Stanford Cancer Institute (SCI), which is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.
* Other duties may also be assigned
- Working knowledge of US CMC regulations as well as ICH and US guidance documents required.
- Bachelor's degree in Life Sciences, advanced degree preferred.
- Experience in CMC operations, regulatory affairs or other relevant experience in investigational stage biologics. Cell Therapy/CAR T experience preferred.
- Ability to contribute to multiple projects/submissions concurrently.
- Strong interpersonal skills and the ability to work in a project team environment.
- Excellent written and oral communication skills in English.
- Strong technical writing and editing skills.
EDUCATION & EXPERIENCE (REQUIRED):
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
- Schedule: Full-time
- Job Code: 4361
- Employee Status: Regular
- Grade: I
- Department URL: http://cancer.stanford.edu/
- Requisition ID: 88123
Location: School of Medicine, Stanford, California, United States
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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