Raymond Kuehner Email & Phone Number

Philadelphia, PA, US

Philadelphia, Pennsylvania, United States

• Coordinating in-process, finished product, and stability testing associated with clinical trial material in a cGMP environment. Solely responsible for the day-to-day management of responsibilities for a team of 15.
• Validation, verification, and maintenance of quality control equipment as well as Method / Technology Transfer of existing methods into the QC Lab. Flow Cytometry, Potency, and PCR subject matter expert.
• Designated training representative for QC Department. Sole duties include ensuring complete training and development of a team of 20.
• Authoring, reviewing, and approving Stability Reports, SOPs, CAPAs, and Deviations while adhering to GDP for the Quality Control laboratory.
• Provide analytical oversight, facilitation, and leadership for OOS investigations, change controls, deviations, CAPAs, risk assessments, and continuous improvement initiatives.
• Define strategic focus of US based QC Functions to address long term planning and corporate goals associated with the autologous program and in-house and external laboratory testing.

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

• Perform and result laboratory assays for DNA typing and Antibody Screening, provide on-call support and report results related to deceased donor or alloantibody testing workups.
• Orient and train new hires / students in testing methodologies employed in the laboratory.
• Validation and implementation of new technology into the workflow of the laboratory.

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

• Extraction of high-quality DNA from blood samples, Buccal swabs, or cultured cells for DNA typing methods.
• Cell separation for engraftment monitoring analysis.
• Antibody screening using Lab Screen techniques.