Senior Manager, Biological Therapy Core Facility Operations
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.
Under the direction of the Executive Director and the Medical/Scientific Director, this position provides leadership, operations, QA and management services to the Siteman Cancer Center BTC (Biological Therapy Core) Facility for both clinical and research procedures. The Director is a partner with extensive knowledge in developing, guiding and advising in technology and advancements in the field of biological therapy including immunotherapy, gene therapy and innovative targeted therapies. This includes but is not limited to project development and strategy, initiation, and conduct; fiscal oversight and oversight of laboratory operations.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Collaborates with Scientific Director to assure the scientific vision and goals for the BTC are achieved in a timely fashion.
- Acts as an advisor at key institutional and external educational sessions regarding the BTC facility, cGMP processes, best practices and current technology and scientific applications.
- This position is the link between basic research and full GMP manufacturing in the clean room laboratories of BTC to conduct research on milestone-driven grant funded projects, leading to development of clinically-relevant cell and gene therapy, vaccines, etc. manufacturing methods into validated processes and procedures to produce commercial ready data.
- Collaborate with Principal Investigators on grant applications for investigators within the university who require BTC services.
- Collaborate with clients on for-profit applications who require BTC services.
Laboratory and QA Oversight
- Expand BTC user base to assure the facility is self-sustaining.
- Develop and monitor operations and services of the BTC facility according to cGMP for both clinical and research applications 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 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 and other required documentation 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: FDA, RAC, PRMC, IBC, HRPO/IRB).
- Establish, write and implement various standardization documents including but not limited to environmental monitoring procedures, maintenance procedures for all BTC instruments and equipment, new laboratory processes for BTC manufacture.
- 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 training inside and auxiliary personnel (physicians, researchers, trainees, staff) in BTC procedures.
- This position will be the Quality Assurance specialist until such time the BTC is at full capacity. Therefore this position is responsible for developing and implementing Quality Assurance standards, policies and procedures and for ensuring continued compliance with these standards and to ensure compliance with cGMP, cGCP, FDA, ICH, CAP and other applicable regulations and standards. This position will have interaction with WUSM or BJH representatives regarding compliance or federal regulations as necessary.
- QA duties include: identifying, establishing, and monitoring standard protocols and processes to assess quality of laboratory services and adherence to WUSM and externally mandated standards by periodic audit and inspection of the facility and records, reporting the findings from such activities to leadership, coordinating feedback and interventions as needed to address quality issues, and establishing and maintaining quality databases and systems such as Deviation reporting, Corrective Action & Preventative Action (CAPAs), Document Control, and Change Control.
- With Siteman Executive Director, Business Director and Associate Director for Shared Resources, establish finance and operations goals and set priorities necessary to continually improve laboratory services and meet the needs of principal investigators who require BTC services.
- Establish operating policies and procedures necessary to provide BTC services.
- Establish annual budget with approval of Siteman Cancer Center administration, and oversee/monitor BTC Facility expenses.
- With Siteman Business Director, responsible for reviewing on at least an annual basis the charge back mechanism for the lab. Track facility usage and ensure appropriate chargeback to individual clients.
- Responsible for developing and negotiation appropriate budgets to assure the BTCF covers costs.
- Ensure compliance with all applicable regulatory agencies and WUSM policies. File all requiredreports and retain records as needed.
- Hire, evaluate and develop laboratory staff.
Minimum of 5 years of managerial experience in a Biological Therapy Core facility providing operational leadership and establishing policies and protocols necessary to run a successful Biological Therapy Core operation. Direct experience with Biological Therapy Core protocols and regulatory oversight required.
- Master’s degree in scientific field is preferred.
- Advanced Certification in laboratory medicine is strongly preferred.
- This position requires a highly motivated individual with the ability to work closely with other members of the laboratory and the department in a Matrix environment.
- Requires strong ability to independently prioritize tasks, and to work under deadline pressure.
- Must have the ability to work independently and efficiently with minimal supervision.
- Executive level project, strategic planning expertise, academic medicine and advanced financial skills.
- A successful track record of leadership in a complex matrix managed environment.
- Outstanding interpersonal and political skills with proven evidence of working effectively both internally and externally with a wide variety of constituents.
- Political skills essential for a complex matrix environment with additional external institutional relationships.
- Demonstrated experience pulling together a high-performing administrative and/or research team and developing the skills and ideas of staff and faculty.
- Must be an established leader in the development and operation of complex, highly regulated facility. Requires extensive knowledge of lab procedures and related regulatory issues.
- Requires ability to collaborate with and meet the needs of a variety of researchers while maintaining and promoting adherence to regulations and protocols.
- Successful experience with cGMP, clean room facilities is optimal.
- Requires 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).
- A history of managing the operations of a complex environment with a history of creating and successful implementation of operating procedures.
The hiring range for this position is commensurate with experience.