Research Scientist II - Study Director (Extractables And Leachables)

Location: Round Lake, Illinois, United States; flexible workplace policy with a required minimum number of onsite days each week. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Salary: $128,000–$176,000 annually, plus potential discretionary bonuses.

Company

Develops healthcare products and technologies focused on improving healthcare delivery and sustaining lives.

What you will do

• Design and execute extractables and leachables studies for medical devices, pharmaceutical products, and combination products.
• Lead internal and external studies, providing technical direction, resource planning, and scientific oversight.
• Coordinate with Analytical Sciences, Toxicology, Biocompatibility, Regulatory Affairs, Quality, Manufacturing, and Program Management.
• Oversee multiple projects across the product portfolio, including scientific quality, regulatory alignment, timelines, and budgets.
• Develop departmental extractables and leachables strategies and improve capabilities and operational efficiency.
• Review and approve protocols, reports, study plans, technical assessments, and regulatory documentation.

Requirements

• Experience with extractables and leachables programs, analytical techniques, mass spectrometry, and using extractables and leachables data for product submissions.
• Proven ability to balance technical, regulatory, business, and organizational objectives.
• Experience managing multiple projects, budgets, resources, and competing priorities.
• Technical leadership experience in a scientific or regulated environment; prior people management experience is required.
• Bachelor's degree with 12+ years of relevant experience, master's degree with 10+ years, or PhD with 8+ years in analytical chemistry, toxicology, materials science, pharmaceutical sciences, or a related discipline.

Nice to have

• Previous people management experience.

Culture & Benefits

• Flexible workplace policy supporting in-person collaboration.
• Medical and dental coverage starting on day one, plus life, disability, and travel accident insurance.
• 401(k) retirement plan with employee contributions and company matching, employee stock purchase plan, and flexible spending accounts.
• Educational assistance, paid holidays, paid time off, family and medical leave, and paid parental leave.
• Commuting benefits, employee discounts, employee assistance, and childcare benefits.