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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 Senior Chemist, 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 studies, method development / validation activities, and routine testing.

Employees in this role are mid-level professionals who collaborate with others on products and projects to complete well-defined analytical and research assignments. Employees in this role typically possess specialized knowledge that has been gained through wide exposure or experience in a relevant technically specialized field. This expertise often combines a broad understanding of relevant practices and precedents, along with the foundational principles and practical experience in preparing samples for microscopical analysis and performing analyses.

These professionals are skilled in developing appropriate protocols for conducting analyses and are integral team members responsible for delivering components of a larger process. They may also provide guidance or supervision to lower-level positions performing well-defined activities. Lastly, these employees typically work under minimal to no supervision at all by the Manager

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:Develop TEM sample preparation and imaging workflow including fixing, embedding, ultramicrotomy, staining / labeling, and imaging, for high resolution imaging of biological components including extracellular vesicles (EV) such as exosomes, collagen fibrils D-banding, etc.Develop expertise and advanced knowledge in focused areas in microscopy, i.e., TEM, histology, and Python programing languageProactively develop the laboratory workflow using GLP and regulatory principalsContributes to and leads in developing and advancing complex and difficult imaging techniques and analysesStreamline image processing and data acquisition workflow including developing AI automation using Python programing languageLeads and performs reviews and improvement of test methods and various procedures in support of overall laboratory continuous improvement initiativesPerform material characterization including foreign matter / particulates analysis, CAPA/NC investigations using combined techniques such as optical, SEM/EDS X-ray microanalysis, FT-IR/Raman MicroscopyPerform chemical analysis and characterization of materials, including but not limited to routine assays of chemical components, determination of impurities, spectroscopy, and chromatography, mechanical testing, rheometry, and thermal analysis where necessaryComply with GLP, OSHA and all internal and external regulations and guidanceDemonstrate excellent organizational skills through maintaining appropriate laboratory behaviorsDesign training plans and create materials for I.M.A.G.E. staff and other laboratory users;Provide training (theory and hands-on) to new R&D lab and Quality Control laboratories personnel on new testing procedures for various biomaterials and medical devicesAssist Manager of I.M.A.G.E. and where necessary, ADL in maintaining the Product Development Laboratories in accordance with GLP and OSHA standardsLeads and participate in the design of laboratory and Test Development and Validation plansLead, mentor and 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 ProceduresTroubleshoot technical issues encountered during testing and method developmentTransfer new analytical methods to Quality Control laboratories in accordance with ISO and FDA standards, which may include final review and/or dispositionProvide direct testing support or testing oversight / guidance to the Quality Control laboratories when they are requesting personnel resourcesDemonstrate excellent communication skills through:Summarizing data and communicating results to the I.M.A.G.E. / ADL and wider R&D teamCommunicates with users regarding laboratory priorities by, for example, participating in product development and R&D meetings and identifying and communicating needs to laboratory managementPreparing reports and presentationsMay serve as liaison for I.M.A.G.E. for various internal customer base and other internal departmentsDemonstrates excellent organizational skills in maintaining databases, articulating laboratory goals and responses, communicating with management regarding laboratory prioritiesProject managementMake arrangements with facilities, safety, and support personnel, and with outside vendors for calibration, testing and other servicesProject and testing coordination including interpersonal and digital communications to interface daily with internal departments and external customers, stakeholders, and collaboratorsMaintains excellent laboratory behavior which includes but not limited to GDP, chemical hygiene and all EHS requirementsDemonstrates excellent analytical and critical thinking skills in analyzing and summarizing data to key stakeholders, and in supporting laboratory prioritiesLeads and conducts laboratory investigations using the appropriate tools and methodologies for all related OOS, OOT, deviations, events, etc.Drives any necessary remediation work related to compliance gaps, audit findings, CAPAs, etc.Prepare test methods and other various procedures for the I.M.A.G.E. and where necessary, ADLSupport management of the Product Development Laboratories to ensure compliance with Integra policies and procedures along with GLP and OSHA requirementsPlan and execute of experiments based on Design of Experiments, including the use of statistical analysis software packagesAssist in the completion of documentation for Design Controls as defined by Integra SOPs and Regulatory organizations such as US-FDA and ISODemonstrates excellent problem-solving and instrument / method troubleshooting skillsComplies with and completes all required internal and external training in a timely manner as well as maintains complete and accurate training recordsPrepares, assists, and acts as liaison for I.M.A.G.E. / ADL in support of internal and external auditsProactively engages in own professional development activities, including engaging Manager of I.M.A.G.E. and Sr. Manager of ADL to help drive progressPerform 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 5-7 years of related experience, a Master’s of Science Degree with 3-5 years of related experience, or a Ph.D. Degree with 0-2 years related experience performing progressively advanced duties at the Senior Chemist, Microscopist level, or equivalent training & experienceExperience in working with a range of imaging instrumentations and sample preparation techniques, including SEM, TEM, ultramicrotomy, immunolabeling, EDS X-ray microanalysis, histology sample preparation including paraffin sectioning, H&E / Masson's trichrome staining, immunohistochemistry; in addition, confocal microscopy and micro-CT a plus.Experience with image processing and quantitative image analysis using Image J, MATLAB, Adobe Photoshop, and other imaging analysis softwareAdditionally, experience with coding and AI Automation such as Java, Python programing language is desirableExperience with test method development and validationWorking knowledge of standard laboratory practices, including GLP, GDP, external standards such as FDA, ISO, USP, ICH and laboratory safetyExperience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentationsExperience with statistics and experimental design (and their related software)Proficiency in Teams, Outlook, OneNotePossesses excellent problem-solving and instrument / method troubleshooting skills and presentation skillsGreat team player, collaborative, dynamic and enthusiast about advancing our in-house imaging and microscopy capabilities

TOOLS AND EQUIPMENT USEDMicroscopy Instrumentation: SEM / STEM / ESEM, EDS, TEM, CPD, sputter coater, confocal, micro-CT, optical, slide scanner, AFM, ultramicrotome, along with along with new and existing test equipment, computers / related software, image processing and analysis, 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 and stand. The employee may be required to travel to all areas of the company. The employee may also 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; writing sample; 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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