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Scientific Director

Responsibilities

Routine Duties

  • ┬áManage the laboratory to meet the cGMP and cGTP requirements for both minimally and more than minimally manipulated cellular therapy products;
  • Supervise bio-banking activities, specifically cell processing, cryopreservation and distribution of off-the-shelf products, and other day-to-day operations of the laboratory;
  • Future supervision of high complexity clinical testing once CLIA requirements are met;
  • Develop laboratory policies and standard operating procedures;
  • Plan and schedule staff assignments and adequate coverage based on workload andproductivity standards.
  • Other duties as assigned.Quality and Regulatory Duties
  • Provide guidance to technologists performing donor/sample tests, proficiency tests, quality control, validation studies, review of processing records and documentation of deviations. Identify and implement performance improvement opportunities related to cellular therapy tasks;
  • Work with the Quality Systems Department to ensure a high level of performance, rapid and appropriate evaluation of root cause, and effective remedial actions to address deviations from performance specifications. Ensure documentation is complete, comprehensive, and maintained;
  • Develop and implement procedures as well as conduct cellular laboratory staff training and competency assessments according to department standards and regulations;
  • Oversee and review through active surveillance all quality control activities including daily quality control, proficiency testing, instrument operation, technical performance and cellular product processing; ensure complete and accurate documentation is maintained;
  • Ensures the laboratory is prepared for state, federal, accrediting body and industry inspections, and represents the laboratory along with Quality Systems for same;
  • Oversee laboratory safety.Business Development Duties
  • Reach out to industry and institutional partners in order to leverage our registry, collection center and laboratory services for provisioning of starting material for further manufacture;
  • Take a leadership role in providing insight and vision in the field of cellular therapy, including any threats or opportunities for us. Monitor and evaluate industry literature, and work closely with experts in the field to identify potential new opportunities in the rapidly changing cellular therapy industry;
  • Develop and support new clinical and research protocols related to cellular therapy by understanding customer needs, negotiating product specifications, and delivering products to customers that meet or exceed their expectations;
  • Explore future opportunities for our involvement in allogeneic cellular therapy and immunotherapy activities that leverage our resources.Knowledge, Skills, and Experience
  • Plan to meet CLIA requirements for a laboratory director performing high complexity clinical testing;
  • Experience in cGMP and cGTP requirements;
  • Understanding of applicable FDA regulations, AABB cellular therapy standards, CAP, CLIA,NMDP,z and other relevant regulatory and accreditation requirements;
  • Experience in minimal and more than minimal manipulation of cellular therapy products;
  • Experience in flow cytometry assays and interpretations;
  • Knowledge of sterile techniques required for cellular therapy product handling andmanipulation;
  • Knowledge of the use of liquid nitrogen to provide a safe, compliant, and cost-effectivecryogenic environment;
  • Demonstrated ability to perform standard data analysis;
  • Demonstrated ability to multi-task;
  • Excellent oral and written communication skills;
  • Strong organizational skills with attention to detail;
  • Ability to work both independently and within teams;
  • Time management skills.TravelAs needed in order to attend relevant industry conferences, and customer meetings.Physical Demands

    This position is basically sedentary with some walking, standing, stooping, and lifting required. Occasional lifting of objects weighing in excess of 20 pounds.

Please send CV to jobs@tseworldwide.com