_South Texas Blood & Tissue is an AABB-accredited blood bank. It operates nine donor centers in South Texas, distributing blood, plasma, platelets, and other components to regional hospitals and emergency first responders. It also provides starting materials to therapeutic developers, and clinical research services. Its apheresis center received FACT accreditation in 2022 for peripheral blood cellular therapy product collection. As an AATB-accredited tissue bank, it offers tissue recovery from living and deceased donors._ **Pay Rate: Hourly $42.90 - $52.00/ Annually $89,232.00 - $108.160.00** Job Title: Manager, Advanced Therapies Laboratory Revision: 0000 Job Code: 700222 Shift: Monday- Friday 8am-5pm FLSA: Exempt Hybrid? N CPF Level: Location: San Antonio Dept.: Apheresis Services Business Unit: STB&T **General Summary** Responsible to perform and coordinate all Advanced Therapies Laboratory operational processes and activites, including accessioning, processing, analytical testing, freezing/storage, distribution, maintenance, and quality control in support of cord blood, apheresis and cryopreservation. Ensure all laboratory procedures are conducted in compliance with prescribed regulations and when required revise or write new policies and procedures. Maintain all technical activities to include training and the performance of high complexity routine laboratory procedures. Manage Advanced Therapies Laboratory staff. Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise. Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes. It is essential that the incumbent have a valid driver's license and be at least 18 years old with a good driving record to meet organization driving standards. **Major Duties and Responsibilities** Essential Tasks Manage and schedule Advanced Therapies Laboratory staff in all departmental operations, to include 24/7 coverage of Advanced Therapies Laboratory, as necessary. Perform and oversee analytical testing laboratory through performance of high complexity, routine and special laboratory procedures. Perform cord blood testing and maintain quality control records within compliance. Perform leukopak cryopreservation and other post-collection procedures including splitting leukopaks, analytical testing, and product cell count and viability testing. Order, receive, inspect, and monitor incoming samples and products for testing and ensure that integrity of the sample is maintained (i.e. temperature, timing, etc.) Perform processing, packaging, banking and labeling of the cord blood according to procedures of FDA, AABB, NMDP, ISO and the organization as required. Coordinate activities of the laboratory to determine priorities regarding processing and testing of cord blood, PBSC collections, donor pre-screening, and leukopak cryopreservation.. Ensure that all aspects from collection, processing, testing, cryopreservation and distribution are integrated. Review paperwork related to processing and analytical testing. Oversee and maintain the Advanced Therapies Laboratory data management system. Ensure the accuracy of the data that has been entered into database through a defined audit and review process. Maintain adequate level of disposable supplies through request for purchase of additional supplies. Oversee daily activity reports related to processing, resolution of discrepancies and retention of products not qualified for release. Train new employees and maintain annual training competencies for all Advanced Therapies Laboratory personnel. Ensure compliance with HIPAA and Human Subjects Research regulations. Write new and update existing SOPs for process improvement, or new customer specifications. Manage integration of electronic record-keeping and batch records. Recognize trends and troubleshoot unusual results and difficulties encountered in all phases of laboratory performance to include purchased goods, environmental, mechanical and product related. Oversee validation of all procedures performed to provide for the safety and efficacy of products to include preventative maintenance. Work with BioMed to ensure all equipment is maintained, validated and calibrated at all times. Attend meetings, seminars, and other workshops as required. Maintain a close working relationship with department management and keep management informed on issues pertaining to the processing. Interview and make recommendations for hiring, terminating, promoting, demoting, orientating, evaluating, counseling and salary changes for department personnel. Establish performance goals and conduct bi-annual performance reviews for all Advanced Therapies Laboratory personnel. Create and revise existing job descriptions to accurately reflect position responsibilities. Initiate Advanced Therapies Laboratory quality improvement initiatives. Perform RCAs and CARs based on trends identified through the QIR process. Participate in strategic resource management of the Advanced Therapies Laboratory program. Participate in budget process for Advanced Therapies Laboratory. Participate in requisition creation and approval process. Process payroll for Advanced Therapies Laboratory staff. Provide and participate in educational opportunities for Advanced Therapies Laboratory staff. Oversee the acquisition and validation of new laboratory equipment and procedures. Participate in the development of relationships with external clients. Oversee and support the development of new products and services as they relate to advanced therapies, leukapheresis, cord blood, umbilical and placental tissues. Performs other duties as assigned. Non-Essential Tasks Run departmental errands as directed. **Education** Requires a Bachelor's of Science Degree from an accredited college or university with major course work relative to the field of assignment. Required major is Medical Technology, or equivalent. Prefer a Master's of Science Degree from an accredited college or university. **Experience** Requires five or more years of laboratory experience. Requires three or more years in a progressive leadership role. Prefer three or more years of advanced therapies laboratory or cellular therapy processing, quality control, and equipment validation experience. **Knowledge** Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies. Must be competent in all aspects of technical procedures, and regulatory requirements for Advanced Therapies. Must be knowledgeable in Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory requirements. Must have a working knowledge of all cord blood processing, analytical testing, equipment and procedures for various technologies, (to include flow cytometry). Must possess Knowledge of Foundation for the Accreditation of Cellular Therapy (FACT) Hematopoietic Cellular Therapy Product Processing accreditation requirements preferred. **Skills** Must be prepared to identify root causes of problems and select the best course of action when circumstances require. Must have the skills to recognize unusual results and troubleshoot testing problems as soon as detected. Must have excellent management skills. Must be capable of operating motor vehicles in all types of weather conditions. Must have excellent written and oral communication skills. Must have strong manual dexterity and technical abilities in the use of laboratory equipment. **Abilities** Must be able to keep information confidential. Must be able to make good sound judgment decisions. Must be able to operate all testing equipment required in the Advanced Therapies laboratory. Must be neat in appearance and well groomed. Must be professional, detail oriented, self‐motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently, and in a team.. We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation! **All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:** • Competitive salary • 100% Employer Paid Life Insurance • 401(k) with Employer Contribution • 100% Employer Paid Long-term Disability Plan • Paid Time Off (PTO) • 100% Employer Paid AD&D • Extended Illness Benefits (EIB) • 100% Employer Paid Employee Assistance Program • Shift Differentials • Group Health Medical Plan with prescription coverage • Paid Holidays • Variety of Voluntary Supplemental Insurances • Incentive Compensation Plan • Voluntary Dental Coverage • Educational Assistance Program • Voluntary Vision South Texas Blood & Tissue Center (STBTC), a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please clickhere (http://www1.eeoc.gov/employers/upload/eeoc\_self\_print\_poster.pdf) . STBTC maintains a Tobacco & Drug-Free Workplace.