Sr. Chemist

Job Description

Job Summary:

• We are seeking a technically strong Senior Chemist who thrives in collaborative environments and values diverse perspectives, recognizing that inclusive teamwork drives scientific excellence and innovation.
• This individual contributor role sits within client’s Peripheral Vascular Health (PVH) Operating Unit Research and Development (R&D) team.
• PVH is dedicated to the treatment of peripheral arterial and venous diseases.
• 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.

Duties and Responsibilities:

• 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.[JS1]
• Recommend utilization of results, adjustments to project Product, 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:

• 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).