Analytical Chemist I – Entry Level

Integra LifeSciences•Plainsboro Township, NJ

7d•$62,100 - $85,100

About The Position

The Analytical Chemist I is responsible for supporting the Research and Development Analytical Laboratory activities, including executing routine testing and supporting senior / staff chemists with protocol execution for Tissue Technology (TT) and Codman Specialty Surgical (CSS) projects as directed, for the purpose of achieving corporate goals. Employees in this role are entry-level professionals who collaborate with others on products and projects to complete well-defined assignments. These employees typically work under supervision by the Manager and/or by other senior-level chemists.

Requirements

Entry-level professionals
Collaborate with others on products and projects to complete well-defined assignments
Work under supervision by the Manager and/or by other senior-level chemists
Good communication skills
Good laboratory behavior
GDP, chemical hygiene and all EHS requirements
Analytical skills in analyzing and summarizing data
Organizational skills
Basic understanding of GLP, OSHA, ICH, USP, ISO, FDA standards

Nice To Haves

Experience with optical microscopy, scanning electron microscopy (SEM) and EDS X-ray microanalysis, Micro-CT, confocal, mechanical testing, rheometry, and thermal analysis
Experience in transferring new analytical methods to Quality Control laboratories
Experience in preparing reports and presentations
Experience with facilities, safety, and support personnel coordination
Experience with outside vendors for calibration, testing and other services
Experience in testing coordination
Experience in maintaining databases
Experience in instrument / method troubleshooting
Experience in developing and supporting new laboratory test capabilities
Experience in developing laboratory workflow using GLP and regulatory principles
Experience in Test Development and Validation plans
Experience in reviewing and improving test methods and various procedures
Experience in supporting internal and external audits
Experience in supporting laboratory investigations
Experience in supporting remediation work
Experience in troubleshooting technical issues

Responsibilities

Perform chemical analysis of products and prototype materials, including but not limited to routine assays of chemical components, determination of impurities, enzymatic degradation, spectroscopy, and chromatography
Perform materials and physical characterization including optical microscopy, scanning electron microscopy (SEM) and EDS X-ray microanalysis, Micro-CT, confocal, mechanical testing, rheometry, and thermal analysis
Comply with GLP, OSHA and all internal and external regulations and guidance
Assist Manager of Analytical Development with documentation tracking in maintaining the labs in accordance with GLP and OSHA standards
Work as part of a team to assist in developing and validating test methods to support the design and development of implantable Tissue Technology products from concept phase through launch, following GLP, ICH, USP and Design Control Procedures
Assist in transferring new analytical methods to Quality Control laboratories in accordance with ISO and FDA standards
Summarizing data and communicating results to the Analytical Development team and wider cross-functional team where needed
Preparing reports and presentations
Make arrangements with facilities, safety, and support personnel, and with outside vendors for calibration, testing and other services
Testing coordination including interpersonal and digital communications to interface daily with internal departments and external customers, stakeholders, and collaborators
Maintains good laboratory behavior which includes but not limited to GDP, chemical hygiene and all EHS requirements
Develop and demonstrate analytical skills in analyzing and summarizing data to key stakeholders, maintaining databases and in supporting laboratory priorities
Demonstrates organizational skills in supporting group responses to laboratory priorities and maintaining databases
Assists in instrument / method troubleshooting
Assists in developing and supporting new laboratory test capabilities
Assists in developing the laboratory workflow using GLP and regulatory principles
Assists or participates in the design and/or execution of Test Development and Validation plans
Assists in the review and improvement test methods and various procedures in support of overall laboratory continuous improvement initiatives
Complies with and completes all required internal and external training in a timely manner as well as maintains complete and accurate training records
Assists in the support of internal and external audits
Supports laboratory investigations using the appropriate tools and methodologies for all related OOS, OOT, deviations, events, etc.
Supports any necessary remediation work related to compliance gaps, audit findings, CAPAs, etc.
Assists with troubleshooting technical issues encountered during physical and chemical characterization
Prepare test methods and other procedures for the analytical development group where necessary
Perform all other duties as required