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Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Chemist II, Microscopist is responsible for supporting all aspects of the Research and Development Imaging and Microscopy Analysis Group and Expertise (I.M.A.G.E.) and the Analytical Discovery Laboratory (ADL) activities, where needed, including CAPA/NC investigations, studies, method development / validation / qualification activities, and routine testing, for Tissue Technology (TT) and Codman Specialty Surgical (CSS) projects as directed, for the purpose of achieving corporate goals.
Employees in this role are early- to mid-level professionals who collaborate with others on products and projects to complete well-defined assignments. Additionally, employees in this role may have the skill and expertise to develop appropriate protocols for conducting analyses. Employees are typically team members with responsibility for delivering components of a larger process. Lastly, these employees typically work under supervision by Manager and/or by other senior-level chemists.
SUPERVISION RECEIVED
Under direct supervision by the Manager of I.M.A.G.E.
SUPERVISION EXERCISED
At the discretion of the Manager of I.M.A.G.E.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, which includes but not limited to the following:
• Perform material characterization including foreign matter / particulates analysis, CAPA/NC investigations using combined techniques such as optical, SEM/EDS X-ray microanalysis, FT-IR/Raman Microscopy
• Perform chemical analysis and characterization of materials using various microscopic techniques including but not limited to SEM, EDS X-ray Microanalysis, Micro-CT, confocal, TEM, optical; additionally, analytical techniques such as spectroscopy, chromatography, mechanical testing, rheometry, and thermal analysis, where necessary
• Comply with GLP, OSHA and all internal and external regulations and guidance
• Develop knowledge of focused test area in microscopy such as SEM/EDS, TEM, micro-CT, histology, image processing and analysis, Python programing language.
• Assist the Manager of I.M.A.G.E. and where necessary ADL in maintaining the labs in accordance with GLP and OSHA standards
• Work as part of a team to develop and validate 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
• Transfer new analytical methods to Quality Control laboratories in accordance with ISO and FDA standards
• Provide direct testing support to the Quality Control laboratories when they are requesting personnel resources
• Demonstrate excellent communication skills through:
o Summarizing data and communicating results to the I.M.A.G.E. / ADL and wider R&D team
o Communicates with users regarding laboratory priorities by, for example, participating in product development and R&D meetings and identifying and communicating needs to laboratory management
o Preparing reports and presentations
o Progress reporting
o Make arrangements with facilities, safety, and support personnel, and with outside vendors for calibration, testing and other services
o Project and 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
• Demonstrate good analytical skills in analyzing and summarizing data to key stakeholders, maintaining databases and in supporting laboratory priorities
• Demonstrates good organizational skills in supporting groups responsible for laboratory priorities and maintaining databases
• Performs instrument / method troubleshooting
• Assists in developing and supporting new laboratory test capabilities
• Assists in developing the laboratory workflow using GLP and regulatory principles
• Perform reviews and improvement of 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
• Participates in the design of laboratory and Test Development and Validation plans
• Supports internal and external audits, as well as 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.
• Assist with and contribute to streamlining imaging processes and data acquisition workflow including AI automation using Python programing language
• Troubleshoot technical issues encountered during testing and method development
• Prepare test methods and other various procedures for the I.M.A.G.E. and where necessary for ADL
• Assist in or may directly train new R&D and Quality Control laboratories personnel on new testing procedures for various biomaterials and medical devices
• Proactively engages in own professional development activities, including engaging Manager of I.M.A.G.E. and Sr. Manager of ADL to help drive progress
• Perform all other related duties required
REQUIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position:
• Bachelor’s Degree in Material Science, Chemistry, Cell Biology, or related discipline with 3-5 years of related experience, or a Master’s of Science Degree with 0-2 years of related experience, performing progressively advanced duties at the Chemist II / Microscopist Level, or equivalent training & experience (Ph.D. Degree not applicable)
• Experience in working with a range of imaging instrumentations and sample preparation techniques, including SEM, EDS X-ray microanalysis, histology sample preparation including paraffin sectioning, H&E / Masson's trichrome staining; in addition, confocal microscopy and micro-CT a plus.
• Experience with image processing and analysis using Image J, MATLAB, Adobe Photoshop, and other image analysis software
• Experience with test method development and validation is desirable
• Working knowledge of standard laboratory practices, including GLP, GDP, external standards such as FDA, ISO, USP, ICH and laboratory safety
• Experience with Microsoft Office software to create reports, spreadsheets, analyze data and preparing presentations
• Experience with statistics and experimental design (and their related software) is desirable
• Proficiency in Teams, Outlook, OneNote
• Problem-solving and instrument / method troubleshooting skills is desirable
• Great team player, collaborative, dynamic, possess intellectual curiosity and enthusiastic about imaging and microscopy and advancing in-house capabilities
TOOLS AND EQUIPMENT USED
Microscopy Instrumentation: SEM/STEM/ESEM, EDS, TEM, CPD, sputter coater, confocal, micro-CT, optical, slide scanner, AFM, ultramicrotome, along with new and existing test equipment, computers / related software, statistical tools.
Analytical Instrumentation (FT-IR, Raman, UV-Vis), wet chemistry techniques
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include but are not limited to the motor/physical abilities required 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 repeatedly sit, listen, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 50 pounds in weight.
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 and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, biological samples, close proximity to controlled/contained radiation source (SEM, micro-CT) and medical wastes.
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 examples 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.
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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. 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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