Senior Chemist, Microscopist

- Mid Level

Fort Collins, CO

Miscellaneous Manufacturing

About the position

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.

Responsibilities

• 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 programming language
• Proactively develop the laboratory workflow using GLP and regulatory principles
• Contributes to and leads in developing and advancing complex and difficult imaging techniques and analyses
• Streamline image processing and data acquisition workflow including developing AI automation using Python programming language
• Leads and performs reviews and improvement of test methods and various procedures in support of overall laboratory continuous improvement initiatives
• 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, including but not limited to routine assays of chemical components, determination of impurities, spectroscopy, and chromatography, mechanical testing, rheometry, and thermal analysis where necessary
• Comply with GLP, OSHA and all internal and external regulations and guidance
• Demonstrate excellent organizational skills through maintaining appropriate laboratory behaviors
• Design 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 devices
• Assist Manager of I.M.A.G.E. and where necessary, ADL in maintaining the Product Development Laboratories in accordance with GLP and OSHA standards
• Leads and participate in the design of laboratory and Test Development and Validation plans
• Lead, 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 Procedures
• Troubleshoot technical issues encountered during testing and method development
• Transfer new analytical methods to Quality Control laboratories in accordance with ISO and FDA standards, which may include final review and/or disposition
• Provide direct testing support or testing oversight / guidance to the Quality Control laboratories when they are requesting personnel resources
• Summarize data and communicate results to the I.M.A.G.E. / ADL and wider R&D team
• Communicate with users regarding laboratory priorities by participating in product development and R&D meetings and identifying and communicating needs to laboratory management
• Prepare reports and presentations
• May serve as liaison for I.M.A.G.E. for various internal customer base and other internal departments
• Demonstrate excellent organizational skills in maintaining databases, articulating laboratory goals and responses, communicating with management regarding laboratory priorities
• Project management
• Make arrangements with facilities, safety, and support personnel, and with outside vendors for calibration, testing and other services
• Project and testing coordination including interpersonal and digital communications to interface daily with internal departments and external customers, stakeholders, and collaborators
• Maintain excellent laboratory behavior which includes but not limited to GDP, chemical hygiene and all EHS requirements
• Demonstrate excellent analytical and critical thinking skills in analyzing and summarizing data to key stakeholders, and in supporting laboratory priorities
• Lead and conduct laboratory investigations using the appropriate tools and methodologies for all related OOS, OOT, deviations, events, etc.
• Drive 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, ADL
• Support management of the Product Development Laboratories to ensure compliance with Integra policies and procedures along with GLP and OSHA requirements
• Plan and execute experiments based on Design of Experiments, including the use of statistical analysis software packages
• Assist in the completion of documentation for Design Controls as defined by Integra SOPs and Regulatory organizations such as US-FDA and ISO
• Demonstrate excellent problem-solving and instrument / method troubleshooting skills
• Comply with and complete all required internal and external training in a timely manner as well as maintain complete and accurate training records
• Prepare, assist, and act as liaison for I.M.A.G.E. / ADL in support of internal and external audits
• Proactively engage 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

Requirements

• 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 & experience
• Experience 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 software
• Experience with coding and AI Automation such as Java, Python programming language is desirable
• Experience with test method development and validation
• 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 prepare presentations
• Experience with statistics and experimental design (and their related software)
• Proficiency in Teams, Outlook, OneNote
• Possesses excellent problem-solving and instrument / method troubleshooting skills and presentation skills
• Great team player, collaborative, dynamic and enthusiast about advancing our in-house imaging and microscopy capabilities