About this job:
This position will actively be engaged in manufacturing and research and development (R&D) functions of the GMP facility. The incumbent in this position will be expected to have primary responsibilities for the isolation and processing of mesenchymal bone marrow cells, and other cell types that may be processed in conformance with strict FDA guidelines. In addition to possessing complex and technically demanding skills, the incumbent must be able to exercise independent judgment and work without supervision throughout the various stages of the cellular harvesting process (which may include isolation of cells through density gradient, separation, purification, or positive/negative selection using antibodies, determination of purity/quality, etc.). The incumbent is also expected to contribute actively to the development and testing of new methodologies and technologies, including the design and execution of experiments, the independent evaluation of new equipment, reagents, and other materials, and to make recommendations based on expertise and experimental results. translational research.
Responsibilities:
- Responsible for all approved manufacturing processes. Functions include but are not limited to isolation, culture, cell count and viability, and cryopreservation of cells. Must exercise independent judgment at multiple junctures of the process, take corrective actions, and troubleshoot as needed.
- Actively participate in the design and execution of experimental R&D initiatives to improve current technologies and methodologies including but not limited to, testing of new media and reagents to determine suitability of use, assessment of new equipment and disposable materials, design of new components used in isolation, and making independent recommendations to Longeveron leadership.
- Responsible for scheduling calibrations and certifications for equipment in the GMP facility.
- Responsible for media preparation, laboratory maintenance, reagent receipt and inspection, data entry and analysis, and stocking of supplies, as necessary.
- Responsible for inventory management including but not limited to cryopreserved product and processed patient samples, supplies and reagents using a LIMS (laboratory information management system) or other inventory mechanism.
- Assist in the development of training programs.
- Maintain appropriate control and quality procedures, ensure compliance with current safety requirements.
- Coordinate laboratory activities with other departments, agencies and entities.
- Maintain knowledge of technological advancements in biotech laboratory testing.
- Prepare and maintain required documentation of procedures, test results; record and analyze data.
- Other duties as assigned.
- May require working weekends and holidays.
Qualifications
· Bachelor or associate degree with a minimum of 2 years of experience in a cGMP environment.
· Fluent (oral/written) English.
· Good interpersonal and organizational skills.
· Ability to work independently.
· Attention to detail and accuracy.
