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