Research Scientist I at Baxter International

Round Lake, Illinois, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in a scientific discipline with 5+ years of experience; or MS with 3+ years; or PhD with 0 years in a relevant field
Proven experience in E&L studies, analytical test method development, and validation
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
Previous experience with people management is highly desirable
Ability to work collaboratively in a team environment, embracing diversity and fostering an inclusive culture

Responsibilities

Collaborate with subject matter experts (SMEs) to craft comprehensive E&L studies that adhere to rigorous scientific and regulatory standards (e.g., ISO 10993-18, USP <1663/1664>)
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
Design and supervise the execution of E&L studies, including method development, validation, and transfer; author protocols and reports incorporating SME insights
Formulate E&L strategies that align with regulatory pathways, biocompatibility considerations, and customer needs
Review E&L data to identify trends and correlations with materials of construction; focus on structural identification of E&L compounds and collaborate with Biocompatibility team on toxicological risk assessment
Lead scientific investigations as part of E&L studies, applying critical thinking to derive conclusions based on sound scientific principles
Maintain understanding of Quality System Regulations and ensure compliance in all research activities, data collection, and reporting

Skills

Extractables and Leachables (E&L)

ISO 10993-18

USP <1663>

USP <1664>

Study Design

Regulatory Affairs

Biocompatibility

Analytical Chemistry

Project Management

Toxicology

Medical Devices

Drug Packaging

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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