Manager, Chem LAb - LeMaitre

·         Serves as the Subject Matter Expert (SME) in QC Chemistry Lab testing.

·         Implements and/or supports new programs, tests, methods, and instrumentation.

·         Prepares protocols and reports for test method validations and instrumentation validations.

·         Supervises and trains QC Chem Lab personnel to ensure inspections are completed in accordance with Standard Operating Procedures, GMP, and Regulatory Requirements.

·         Provides technical direction to QC Analysts in both mechanical inspections and QC chemistry testing.

·         Prioritizes the completion of QC Chem Lab inspection tasks to meet production deadlines. Reviews and audits documentation to ensure accuracy.

·         Organizes and maintains common chemicals and reagents and non-chemical stocks (e.g., labware, etc.)

·         Responsible for keeping the Chem Lab clean and orderly to ensure safety and prevent contamination.

·         Oversees analysis of in-process and finished formulations according to standard operating procedures.

·         Leads and/or performs HPLC analysis on various solutions such as ALS, fixation, storage, etc. using Chromeleon 7.2 software.

·         Directs and/or performs GC analysis on various solutions such as IPA, HFIP using TotalChrom software.

·         Guides and/or performs surface analysis using SEM techniques and thermal analyses using DSC technique on PTFE grafts.

·         Ensures mobile phase, dissolution media, standards and samples of assay, content uniformity and related substance testing are done correctly.

·         Conducts lab testing, gathers data, carries out the basic investigations (and performs equipment calibration system management).

·         Measures GLUT concentrations for various solutions using spectrophotometer.

·         Guides and/or performs purity testing, reaction monitoring, related substances, and assay testing.

·         Guides and/or performs calibration of laboratory systems, daily pH meter calibration and temperature monitoring of lab.

·         Guides and/or determines water permeability for vascular grafts, along with determining tensile forces on sterile vascular grafts.

·         Guides and/or measures moisture content of collagen utilizing Mettler Toledo V20 Karl Fischer Volumetric Titrator.

·         Compiles and reviews data for compliance with specifications and documentation of test procedures. Identifies abnormalities and prepares reports.

·         Performs Data integrity and data maintenance of all Data generated on a weekly/monthly basis.

·         Adheres to company policies, procedures, and documentation requirements.

·         Treats others with courtesy, sensitivity, and respect at all times.

·         Other duties as assigned.