Washington University of St. Louis Siteman Cancer Center in St. Louis, Missouri
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location
This position is in the Siteman Cancer Center. This position is for the Medical School Campus.
This position provides leadership and management services to the Siteman Cancer Center BTC (Biological Therapy Core) Facility, including lab maintenance, design and development; short and long term oversight of laboratory operations; project development, initiation, and conduct; training and selection of staff; rate-setting for lab services; and overall budget management.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Laboratory Oversight
- Expand, develop and monitor operations and services of the BTC facility according to cGMP and other applicable state and federal regulations.
- Develop, conduct, and monitor the application of all Standard Operating Procedures (SOPs) regarding BTC facility operations and processing in collaboration with the Quality Assurance Coordinator, to include, SOPs for training of WUSM and auxiliary personnel, and SOPs for the manufacture of special cGMP products, other than cellular products, needed for clinical trials (Special Process Development).
- Develop and implement laboratory processes to aid investigators in moving research into the BTC lab in preparation for IND submissions and clinical trials for gene and cell therapies.
- Assist investigators with preparation of submissions to applicable regulatory authorities (to include: RAC, PRMC, IBC, HRPO/IRB).
- Establish, write and implement various standardization documents.
- Establish and implement environmental monitoring procedures for the BTC Facility.
- Develop, implement and ensure compliance with maintenance procedures for all BTC instruments and equipment.
- Provide cGMP compliance consulting to the Human Research Protection Office.
- Collaborate with Principal Investigators on grants and grant applications for investigators within the university who require BTC services.
- Provide technical and managerial oversight of all clinical processing in the BTC facility.
- Provide support for investigators in all activities being carried out in the facility including implementation of new laboratory processes for BTC manufacture.
- Participate in the writing and creation of scientific papers and abstracts.
- Educational and Academic Functions
- Oversee and conduct training courses in cGMP compliance for clinical nursing personnel and other personnel (e.g., “Necessary Elements” Course).
- Train inside and auxiliary personnel (physicians, researchers, trainees, staff) in BTC procedures in collaboration with the Quality Assurance Coordinator.
- Present at key institutional and external educational sessions regarding the BTC facility and cGMP processes, speaking at scientific and other symposia.
- Participate as a member of the Human Research Protection Office (HRPO) at Washington University School of Medicine and Barnes-Jewish Hospital’s, New Protocol Committee.
- Participate as a member of the Institutional Biosafety Committee (IBC) at Washington University School of Medicine.
- Establish operating policies and procedures necessary to provide BTC services.
- Establish annual budget with Siteman Cancer Center administration, and oversee/monitor BTC Facility expenses.
- In conjunction with the Scientific Director and Siteman Senior Leadership, establish goals and set priorities necessary to continually improve laboratory services and meet the needs of principal investigators who require BTC services.
- Assist Siteman Administration in utilizing a charge back mechanism for the BTC core lab. Track facility usage and ensure appropriate chargeback to individual investigators.
- Ensure compliance with all applicable regulatory agencies and WUSM policies. File all required reports and retain records as needed.
- Hire, evaluate and develop laboratory staff.
- Support the Quality Assurance Coordinator in the carrying out of Facility QA functions.
Master's degree in scientific field required.
- Advanced Certification in laboratory medicine is strongly preferred.
- Minimum of 5 years of managerial experience in laboratory providing operational leadership, and establishing policies and protocols necessary to run a successful BTC operation is strongly preferred.
- Direct experience with BTC protocols and regulatory oversight is strongly preferred.
- Must be an established leader in the development and operation of BTC facilities.
- Ability to work independently and efficiently with minimal supervision.
- Ability to independently prioritize tasks, and to work under deadline pressure.
- Excellent verbal and written communication skills with the ability to interact effectively with a wide variety of individuals, including laboratory and clinical investigators, support staff, national and federal regulatory and fiscal representatives (NIH, NCI, FDA, OHRP, etc).
- Extensive knowledge of BTC lab procedures and related regulatory issues.
- Excellent computer skills and be proficient in the use of all Microsoft Office products, primarily Word, Access and Powerpoint.
- Attention to rigorous documentation and compliance is essential.
- Ability to collaborate with and meet the needs of a variety of researchers while maintaining and promoting adherence to regulations and protocols.
Base pay commensurate with experience.
Retirement Savings Plan
22 vacation days
8 Paid Holidays
Tuition benefits for employee, spouse and dependent children
Free Metro Link/ Bus pass
Free Life Insurance
Health, Dental, Vision
Health Savings Accounts (HSA)
Long Term Disability Insurance
Flex Spending Plan
Med School HR website (medschoolhr.wustl.edu)
Applicant Special Instructions
- Be on call during nights and weekends; presence frequently required in the laboratory on weekends for monitoring and manufacturing.
- Functions in a medical laboratory setting, with strict sterile and standardized environmentally controlled conditions.
- Travel required to occasional overnight professional meetings/conferences.
- Frequent meetings on WUMC campus.
- Computer use 2-4 hours per day.
Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
Job Title: Director, Biological Therapy Core Facility Operations - Siteman Cancer Center - 41400
Job ID: 41400
Location: Medical School
Full/Part Time: Full-Time