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 all processes (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 collateral materials, and to make recommendations based on expertise and experimental results.Essential Duties and 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.
• Maintain appropriate control and quality procedures, ensure compliance with current safety requirements.
• Coordinate laboratory activities
• Maintain knowledge of technological advancements in manufacturing and product related testing
• Prepare and maintain required documentation of procedures, test results; record and analyze data.
• Other duties as assigned.
• May require working weekends and holidays.Requirements and Qualifications
• Bachelor or associate degree with a minimum of 2 years of experience in a cGMP environment.
• Good interpersonal and organizational skills.
• Ability to work independently.
• Attention to detail and accuracy.
• Demonstrated leadership, interpersonal, problem solving, and conflict resolution skills.
• Thrives in a start-up environment where it is critical to take initiative, and get things done with limited instruction and oversight.
• Advanced proficiency in Outlook, Word, Excel, PowerPoint, etc.
• Read, write and speak fluent English; excellent verbal and written communication skillsWork Environment
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.Compensation
Commensurate with experience. Eligible to participate in equity incentive plan, retirement plan, healthcare benefits, paid time off and discretionary bonus.
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