Manager, Chem LAb

LeMaitre Vascular - Burlington, MA

Burlington, MA

Miscellaneous Manufacturing

About the position

Oversees all required chemical tests and analysis for Quality Control related to product release.

Responsibilities

• 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.

Requirements

• Bachelor's degree required. BS/MS in Chemistry preferred.
• 10 years of related experience.
• Ability to write technical and business reports and correspondence.
• Ability to speak effectively before groups of employees and management of the organization.
• Strong written, verbal, analytical, and interpersonal skills.
• Self-motivated.
• Ability to work independently and in teams.
• Ability to multitask.
• Time management and organizational skills.
• Possesses knowledge of a wide variety of chemical test instrumentation (GC, HPLC, UV-VIS, SEM, DSC, Instron, etc.).
• Proficient with Microsoft Office and Chemical Test Instrumentation Software.