Position Summary: Responsible for managing all activities and daily operations in the cell production and manufacturing facilities. Knowledge of hematopoietic stem cell (HSC) processing, mesenchymal stem cell (MSC) processing/manufacture, cellular analysis, aseptic operations, and support systems are essential. Demonstrated managerial skills and a strong working knowledge of regulatory compliance requirements for the production of biologics used in clinical studies are essential. Responsible for hiring, training, supervising and evaluating staff. Remains current regarding technical processing/manufacturing requirements and develops/modifies production methods to fully address such issues. Prepares validation protocols, SOPs, material specifications and develops new client master batch records. Manages cell manufacturing operations assuring customer satisfaction and compliance with appropriate regulatory standards including but not limited to the U.S. FDA GMP regulations.
- Manages all operating procedures, administrative operations, validation studies and the quality management program of the cell processing and cell manufacturing laboratories in compliance with AABB, AATB, FACT, CAP, CLIA and FDA regulations. Must have proven proficiency with GTP, GLP, GMP and GCP.
- Collaborates with the Laboratory Director, Medical Director, and R&D Director to establish and define goals, objectives, and operational plans that support the scientific and clinical goals and objectives as they relate to advancing cellular therapy for the treatment of malignant and non-malignant disease.
- Collaborates with the Laboratory Director, Medical Director, and R&D Director to determine the need for new or updated methodology and manages validation of new methods of production, associated quality control assays, and all associated standard operating procedures (SOP), master process records and staff training programs.
- Manages the day-to-day activities of the cell production and manufacturing facilities and is actively involved in reviewing and improving operational procedures in the laboratory. Analyzes workflow and recommends methods for effective and efficient operation.
- Manages program budget development and implementation; prepares and implements development of clinical trial budgets, manufacturing budgets and grant services budgets.
- Serves as an expert, utilizing scientific knowledge and professional judgment in the design, implementation, and analysis of biologic product manufacturing.
- Manages processing and manufacturing activities and evaluates the integrity of processes and quality of products by monitoring safety, purity, potency, accuracy, and precision.
- Oversees appropriate completion of all components of laboratory operation including: standard operating procedures, validation procedures, document control and record keeping, reports of adverse reactions, accidents, deviations/variances and corrective action plans.
- Participate in the training and qualification of staff, creation and review of batch production and testing and generation of facility compliance documentation.
- Ensure appropriate and timely product supply chain management as needed for production and manufacturing activities.
- Other responsibilities may also be assigned
PhD in medical technology, life sciences, engineering or equivalent is preferred. Master’s degree and related experience including supervisory experience or a combination of relevant education and experience will be considered. Experience with hematopoietic stem cells and mesenchymal stem cells required. The ideal candidate will have 5+ years of industry experience in a cGMP compliant work environment and 3 years management experience. Experience with AATB, AABB and or FACT accreditation is a plus. Blood banking experience is a plus.
- Experience in a cell production and manufacturing involving the complex scheduling and coordination of staff, materials and manufacturing operations required.
- Experience in interactions with federal agencies, i.e. FDA.
- Excellent written and verbal communication and organizational skills and superb attention to detail.
- Experience in clinical research management and oversight, including project management in a dynamic research setting.
- Experience in developing and implementing multifaceted projects.
- Experience with MS Office products and database applications required.