Research And Development Chemist

We are seeking a skilled R&D Chemist with a strong background in formulation, chemistry, and chemical engineering to join the dynamic product development team. Salary range: 90k -110k a year (Based on experience) Key Responsibilities: R&D Chemist Lead the development and optimization of medical lubricants for healthcare applications, including surgical, diagnostic, and therapeutic products. Conduct formulation studies to ensure safety, effectiveness, and biocompatibility, optimizing for patient safety and regulatory compliance. Design scalable manufacturing processes to ensure consistent, high-quality production. Regulatory Compliance (510(k) & PMA): Collaborate with regulatory teams to support FDA 510(k) and PMA submissions for medical lubricant products. Prepare documentation for regulatory filings, including test protocols and reports. Stay updated on FDA regulations, ISO standards, and other relevant medical device guidelines. Material & Test Specification Development: Work with cross-functional teams to define material specifications and develop testing protocols. Lead efforts to assess physical, chemical, and biological properties of lubricants, ensuring biocompatibility and performance. Formulation & Process Optimization: Apply chemical engineering principles to optimize lubricant formulations and manufacturing processes. Use Design of Experiments (DOE) and Statistical Process Control (SPC) to refine processes and improve product performance. Collaboration & Cross-Functional Support: Collaborate with R&D, quality assurance, clinical, and manufacturing teams to ensure successful product development and commercialization. Provide technical expertise and support throughout the product lifecycle. Documentation & Reporting: Prepare detailed documentation, including formulation reports, test protocols, technical specifications, and regulatory submissions. Ensure compliance with Good Documentation Practices (GDP) and relevant regulatory standards. Design Control & Product Lifecycle: Manage the design and development lifecycle, ensuring compliance with design control regulations and successful product launch. Support the creation of product requirements, design verification, and validation activities. Qualifications: R&D Chemist Bachelor’s or master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related field. Experience in formulation design, particularly for medical devices, is required. 2-6 years of experience in formulation development or chemical engineering within the medical device or pharmaceutical industries. Hands-on experience with medical lubricant formulations and biocompatibility testing is preferred. Experience supporting FDA 510(k) or PMA approvals is highly desired. In-depth knowledge of chemical engineering principles, including fluid dynamics, viscosity, and material compatibility. Familiarity with biocompatibility standards (ISO 10993, USP testing) and regulatory requirements (FDA, ISO 13485, GMP). Proficiency in Design of Experiments (DOE) and Statistical Process Control (SPC). Ability to create material specifications, test protocols, and regulatory documents. Proficiency in Microsoft Office and laboratory data management systems. Preferred Qualifications: R&D Chemist Experience with drug/medical device combination products, particularly those involving lubricants. Familiarity with international regulations, including European Union Medical Device Regulations. Certification in Good Laboratory Practices (GLP) or related quality standards. Job Type: Full-time Pay: $90,000.00 - $110,000.00 per year