Baxter is looking to solve the business and technical problem of designing and leading Extractables and Leachables (E&L) studies for medical devices and drug product packaging to ensure alignment with industry standards and regulatory requirements, while also supporting innovative product development.
Requirements
- Proven experience in E&L studies, analytical test method development, and validation is essential.
- Strong knowledge of analytical chemistry techniques (e.g., LC/MS/UV, GC/MS/FID, ICP-MS) and chemical characterization standards for medical devices and drug packaging.
- Familiarity with regulations governing extractables and leachables, particularly for Container Closure Systems and medical devices.
Responsibilities
- Collaborate with subject matter experts (SMEs) to craft comprehensive E&L studies that adhere to rigorous scientific and regulatory standards.
- Lead and coordinate E&L studies both internally and at external laboratories, ensuring high-quality execution with minimal oversight.
- Engage with diverse teams across chemistry, biocompatibility, regulatory affairs, program management, manufacturing, and toxicology to drive project success.
- Interact with regulatory authorities for product submissions, pre-submission meetings, and addressing queries, ensuring our products meet the highest standards of safety and efficacy.
- Design and supervise the execution of E&L studies, including method development, validation, and transfer, while authoring protocols and reports that incorporate insights from various SMEs.
- Formulate E&L strategies that align with regulatory pathways, biocompatibility considerations, and customer needs to ensure our products are both innovative and safe for patients.
- Review E&L data to identify trends and correlations with materials of construction. Focus on the structural identification of E&L compounds and collaborate with the Biocompatibility team on toxicological risk assessment.
Other
- A Bachelor’s degree in a scientific discipline is required, with 10 years of experience; an MS with 5-7 years; or a PhD with 3 years in a relevant field.
- Previous experience with people management is highly desirable.
- Ability to work collaboratively in a team environment, embracing diversity and fostering an inclusive culture.
- Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
- The estimated base salary for this position is $120,000 to $165,000 annually.
