Manager, Chem LAb
Overview:
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.
Management Responsibilities:
- Sets goals and provides clear direction
- Provides training, coaching, feedback, and recognition.
- Responds to department employees’ needs and questions as needed.
- Supports department employees’ career goals and development.
- Communicates updates to department employees in a timely manner.
- Addresses department employee concerns immediately.
- Addresses performance and behavior issues appropriately.
- Serves as a role model to employees across the organization
- Communicates updates to department employees in a timely manner
- Addresses department employee concerns immediatel
- Addresses performance and behavior issues appropriately.
- Serves as a role model to employees across the organization.
Qualifications:
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.
EEO Statement:
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.
This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.
Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time.Please contact LeMaitre HR at HR@lemaitre.com.