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The Sr Lab Technician is responsible for supporting the R&D Laboratory activities for Tissue Technology projects for the purpose of achieving departmental and corporate goals. Employees in this role will perform duties to support studies, routine testing, method development/design, validations, continuous improvement, equipment qualifications and laboratory operations in compliance with Integra’s policies and the FDA Quality System Requirement.

Tasks are to be self-directed or completed under a limited degree of supervision by the manager and/or by other senior-level R&D staff, with oversight focused only on complex new assignments.

The Sr Lab Technician is trained in standard and experimental processing methods for testing and to help determine the appropriate approach for ongoing work and new assignments. These methods may involve the use of biological and chemical materials, histology, as well as manual and powered cutting tools. Laboratory techniques also often involve the use of hazardous materials. In these duties and others, attention to safety is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily, which includes but are not limited to:

• Maintain a functional, safe, and effective laboratory and ensure that all equipment meets standards for laboratory research and GxP purposes, when applicable

• Perform physical characterization and analysis of tissue derived materials, including but not limited to, mechanical testing, particle sizing, moisture analysis, gel electrophoresis, histological staining, and thermal analysis

• Work as part of a team to assist in developing and validating test methods to support design and development projects

• Demonstrate good communication skills through:

• Summarizing data and communicating results to R&D and other departments

• Preparing reports, presentations and progress reports, when needed

• Articulating laboratory goals and communicating with management

• Develop and demonstrate skills in analyzing and summarizing data to key stakeholders, maintaining databases and supporting laboratory priorities

• Coordinate with the equipment maintenance team, facilities and/or outside vendors on the purchase, onboarding, qualification and maintenance of new or existing equipment and develop necessary documentation

• Assists in developing and supporting new laboratory test capabilities

• Maintain and improve the laboratory workflow using GLP and regulatory principles

• Assist and participate in the design and execution of test method development and validation plans

• Assist and lead continuous improvement initiatives; Initiate improvement of protocols, processes and increase efficiency of lab operations on a routine basis

• Write, collaborate and review protocols, procedures and reports, as needed

• Assist in the support of internal and external audits

• Support any necessary remediation work and investigations related to compliance gaps, audit findings, deviations, data integrity, CAPAs, non-conformances, etc.

• Maintain documentation of all studies and testing performed following GDP guidelines

• Interface with Manufacturing, Quality, Regulatory, Research & Development, Sales, Marketing, and outside vendors to accomplish assigned tasks

• Lead inventory management and tracking of inventory supplies in the lab

• Handle gases (e.g. Liquid Nitrogen, Carbon Dioxide and Nitrogen Cylinders) safely

• Responsible for laboratory housekeeping. These duties may include cleaning of laboratory spaces and classified (clean room) spaces along with duties related to the upkeep and cleaning of laboratory equipment, instruments and common laboratory area

• Develop and implement the use of electronic laboratory notebooks

• Act as an informal resource for colleagues with less experience and may help train colleagues in laboratory techniques and overall lab operations

• Perform other duties as assigned

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• High School Diploma with 5+ years of experience performing duties at a Sr Lab Technician level or equivalent training & experience (M.S. and Ph.D. Degree not applicable)

• Experience working within a formalized FDA or ISO Quality System

• Working knowledge of Good Manufacturing Practices (GCP) and /or Good Laboratory Practices (GLP) as well as safety protocols

• Experience in working with one or more of the following:

• Thermal Analysis (e.g. DSC, TGA, TMA)

• Physical Testing (e.g. Tension/Compression, Rheology, Particle Size Analysis)

• Biochemical Assays (e.g., ELISA, SDS-PAGE, Western Blot, Picogreen)

• Experience with one or more of the following is desired:

• Instron Mechanical Tester

• Differential Scanning Calorimeter (DSC)

• Particle Size Analyzer / Mastersizer

• Microplate reader or CLARIOstar

• Moisture Analyzer

• Scanning Electron Microscope

• Experience in implementing scientific procedures, methods, and tools for the manufacture and testing of medical products

• Experience with test method development and validation is desirable

• Problem-solving and instrument / method troubleshooting skills is required

• Experience with Microsoft Office to develop and/or collaborate on reports, spreadsheets and data analysis

• Experience with statistics, experimental design and multivariate analyses (and their related software) is a plus

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, and copy machine as well as other general office equipment. Ability to use general and specialized laboratory equipment.

Equipment and tools used, but no limited to: Mechanical Instrumentation (Instron mechanical tester), Biochemical Instrumentation (Gel Electrophoresis), Microscopy Instrumentation (SEM, light microscopy), Histology Instrumentation (tissue processing, tissue embedding, tissue cutting, staining), Statistical tools (Excel, Minitab), along with new and existing manufacturing and test equipment.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee:

• Must be able to stand and/or sit for extended periods of time

• Must be able to push, pull, squat, bend, and reach above shoulders

• Repetitive use of hands

• Must have the ability to view computer screen for extended periods

• Must be able to lift and carry objects up to 20lbs

• May need to use common hand and power tools

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous materials that include, but are not limited to, flammable and corrosive liquids and chemicals, compressed gases, sharps, airborne particles, proximity to controlled/contained radiation source (SEM), and medical waste.

The condition of this position is a combination of lab/office setting, with the majority of the time spent in the lab setting. Personal protective equipment (PPE) is required and provided. The employee is required to work with common laboratory chemicals in laminar fume hood with proper PPE and may require occasional wearing of sterile gowning attire when entering certain parts of facility.

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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