Sr Chemist - Exempt

The Senior Chemist applies fundamental chemistry principles to develop, characterize, and validate safe and effective medical device products that address unmet patient needs in venous disease. Responsibilities include providing chemistry technical support to released and emerging products, including method execution, data interpretation, and material- and process-related investigation. This role requires close collaboration with cross-functional partners in R&D, Manufacturing, and Quality to deliver business and technical objectives.

A Day in the Life

As a Senior Chemist, you will focus on advancing existing technologies and supporting the introduction of new technologies and therapies. You will independently plan and execute projects from design through implementation, applying specialized technical expertise while adhering to established policies and quality systems.

• Conduct exploratory research to generate new knowledge and potential products; conceive, organize, promote, and execute ideas and plans to expand chemistry’s role in product discovery and chemical approaches to meet exploratory objectives.
• Develop research proposals that provide a technically and economically sound basis for new or improved products, synthetic methods, processes, and analytical or physical testing techniques.
• Recommend utilization of results, adjustments to project scope, or termination of projects based on technical findings.
• Plan and execute larger, moderately complex assignments independently under limited supervision; lead small projects or processes as needed.
• Perform sample preparation, testing, and data generation using a range of analytical instrumentation; operate and troubleshoot analytical equipment.
• Lead and/or participate in the development, qualification, and implementation of new analytical instrumentation and automation technologies.
• Lead and/or perform analytical test method development, transfer, qualification, and validation.
• Lead and/or perform studies supporting process characterization, optimization, and validation.
• Perform statistical analysis and interpretation of experimental data; provide in-depth technical assessments and recommendations.
• Author technical protocols, reports, and presentations of an analytical and interpretive nature; communicate results to cross-functional audiences.
• Drive continuous improvement of processes, systems, and products to enhance performance within the job area.
• Develop strong partnerships and work effectively with cross-functional teams.
• Act as a technical mentor by providing guidance, coaching, training, and review of work performed by less-experienced professionals.
• If required, support day-to-day operations of the R&D analytical laboratory, including inventory management, supply ordering, instrument maintenance, and implementation of lab safety practices.
• Perform all job functions in compliance with applicable GMP, GLP, ISO standards, FDA and international regulatory requirements, and Good Documentation Practices (GDP).

Must Have – Minimum Qualifications

• Baccalaureate degree with a minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years of relevant experience OR PhD with 0 years of relevant experience

Nice to Have

• Advanced degree in chemistry, chemical engineering, or related technical field
• 5 years of experience in R&D within medical devices or pharmaceutical industries
• Industry experience with new product development and sustaining project support
• Expertise in combination device analytical test method development and validation (for example, HPLC, GC, dissolution, bioassay)
• Formulation and testing experience with adhesives; cyanoacrylates preferred
• Expertise with analytical instrumentation, including troubleshooting (for example, dissolution USP apparatuses, HPLC-DAD, GPC, GC-FID/MS, Karl Fischer, FT-IR, UV-Vis)
• Strong problem-solving capabilities
• Solid oral and written communication skills
• Ability to manage and prioritize multiple tasks and lead projects
• Experience in moderate and complex data analyses using statistical techniques
• Experience using chromatography software such as Empower and MassHunter
• Experience using common electronic documentation software (for example, MAP, Agile, or equivalent)