Manager Cellular Therapy Lab Ops

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Make a Difference

Management all laboratory operations to achieve set strategic goals and ensure compliance with all rules regulations policies and procedures for the cellular therapy processing laboratory. Provides leadership to staff in all activities performed by the laboratory. Advocates for appropriate equipment and resources to meet safety and regulatory guidelines while functioning efficiently meeting productivity goals and serving patient care needs. Oversees the cell processing facility daily operations to achieve and maintain accreditation.

Exceptional Skills and Qualifications

Applicants for this position should be able to collaborate with others in a team setting have excellent communication skills and a positive attitude toward problem-solving.

• 4 year / Bachelors Degree bachelors degree in any of the biological sciences (Required)

• Masters Degree in any of the biological sciences (Preferred)

• 2 years: Minimum of two years experience in the scope of processing activities for stem cell transplant and cellular therapies performed by the facility. (Required)

• Regulatory compliance: Responsible for timely communication of issues and policies to staff and to external groups that may be affected by the change. Provides planning and oversight for continued readiness of the departments clinical laboratories to meet institutional state and federal guidelines. Responsible for reviewing and editing standard operating procedures and policies ensuring compliance with Good Laboratory Practice (cGTP) regulations and applicable accreditation agency standards including but not limited to FDA FACT CAP and CLIA. Oversee proper documentation of deviations investigations and associated corrective actions. Participate in process improvement projects. Responsible for overseeing quality control testing procedures and proficiency testing programs in order to maintain regulatory compliance as well as provide patients with high quality and safe products. Assist with investigational new drug (IND) documents. Serves as an internal and external expert on cellular therapy and the CTL. Works with the Legal and Research team on execution of collaboration and partnership agreements with sponsors. Responsible for identifying areas affecting laboratory procedures and policies and providing support in the inspection process. Ability to educate staff on the applicable regulatory requirements defined in policies and procedures. Participate in regular meetings with the senior leadership team. Provides timely communication of relevant information to CTL personnel and maintains communication between activities. Participate in departmental institutional and external committees advisory boards as requested and appropriate.

• Quality Management: Maintain and support the CTL quality management plan in compliance with all applicable regulatory bodies and agencies. Participate in resource review to prevent waste while ensuring all operations work effectively and efficiently. Coordinate final review of product/patient folder documentation in a timely and efficient manner with quality assurance for release of product for Budgetary

• Accountabilities: Assist in a yearly forecasting budget which will include but not be limited to defining all equipment required to perform the clinical operations and participating in the forecasting of number of procedures. Collaborate on annual procedure volume projections annual operating and capital planning budgets productivity and quality goals staffing space and equipment management. Assist with preparation of budgets for clinical protocols based on understanding of scientific processes and resources required. Provide recommendations for replacement or purchase of new equipment. Cellular Lab Accountabilities: Plan and oversee the daily operations toward achievement of strategic goals for the cellular therapy laboratory (CTL). Responsible for the implementation of novel technologies into the laboratory which will include but not limited to scale up of procedures design and writing of Validation Plan complete documentation of results. Serve as operational and technical resources to staff during working and non-working hours as needed. Serve as a mentor and coach to staff conduct specific training if needed and review competency assessment of staff. Oversee the development and completion of assigned projects that are critical to daily work in the laboratory. Support the generation of documents for the study and all components required for patient safety and FDA inspections. Participate in care planning conferences and other department functions conferences committees as requested. Plan and conduct in-service sessions on advances in new technology. Work closely with institutional facilities to ensure the laboratory facility is maintained according to FDA guidelines DTP and GMP requirements. Ensure facilities have appropriate equipment and resources and meet safety and regulatory guidelines while functioning efficiently and meeting productivity goals and patient care needs. Work closely with vendors to ensure the necessary services around equipment reagents and supplies meet all regulatory requirements. Advocate with vendors to support the latest technology to support an efficient and effective work environment. Provides adequate systems to manage track and securely store product/patient files to meet or exceed institutional and external regulatory guidelines (FDA F ACT and CAP).