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Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Summary

Baxter has an open position for a Senior Research Scientist (SRS) within the Medication Delivery Business unit chemistry department.  The incumbent will be a recognized leader in their area of expertise of analytical chemistry and may supervise other scientists. This Senior Research Scientist position is responsible for technical leadership in the Extractables & Leachables (E&L) laboratory as well as analytical method development and validation activities.  The ideal candidate will have extensive experience designing and executing E&L studies for parenteral drug packaging as well as Medical Devices registered globally (USP <661.2> and ISO 10993-18).

In this role the SRS will plan, lead and perform complex analytical studies that contribute to the safety profile of products by establishing the E&L profiles for drug packaging, medical devices as well as other impurities investigations. The incumbent is expected to lead cross functionally,  interfacing with Regulatory, Toxicology and Program management functions.  Responsibilities will include representing the business unit during regulatory and industry engagement.  The incumbent is also expected to contribute to the departments overall technical vision for innovative analytical processes or new scientific ideas that incorporate several related disciplines, where innovative thinking is required.

Essential Duties and Responsibilities

• Designs and executes studies to meet requirements in USP <1663> and <1664> or ISO 10993-18.
• Prepare and review detailed analytical testing protocols, reports and regulatory dossiers.  
• Present information and engage in technical discussions with multiple stakeholders including technical teams, management and regulatory authorities. 
• Influence internally and externally and interact with regulatory agencies.
• Develop and qualify analytical chemistry methods for product support and registration. 
• Leads analytical studies at CRO for complex non-routine analyses.  Mentors and develops staff. 
• Create and drive innovative solutions to chemical characterization of complex systems. 
• Develops and maintains a comprehensive understanding of the scientific literature and regulatory feedback to anticipate and evolve analytical testing requirements.
• Utilizing the latest state of the art MS capabilities / techniques, analytical software and databases to identify and quantify chemical species e.g. leachables, extractables, degradation/reaction products, additives, etc.
• Routinely design complicated experiments that lead to a fundamental understanding of extractables, leachables (E&L) and analytical problem solving to resolve unique and complex challenges. 

• Develop state-of-the-art analytical techniques/processes (design, quality improvements research techniques, etc.) that span multiple disciplines.

• Further recognition can be evidenced by presentations at external conferences, published articles in peer review journals and/or holding of multiple patents.

Qualifications

• Well versed in analytical chemistry techniques used for E&L including mass spectroscopy and high resolution MS.
• Driven to deliver project milestones on time in full
• Detailed and disciplined in planning and execution
• Able to manage multiple projects simultaneously, independently and through others
• Contribute positively to cross functional teams in a collaborative and diverse work environment
• Exceptional interpersonal and team communication skills.  Able to engage varied audiences
• Comfort with engaging with regulatory authorities and external industry leaders
• Experienced in regulated laboratory operations having an in-depth knowledge and understanding of GxP and related regulations and guidance and is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations

Education and/or Experience

• Bachelor's degree in a scientific discipline with at least 20 years, MS with at least 15 years or PhD with 8 years of relevant work experience.
• Previous experience in E&L for pharmaceutical packaging, medical device and/or combination products.
• Previous experience with analytical test method development and validation.
• QSR research lab experience essential and GMP experience desirable.
• Research lab experience includes cross-functional teamwork.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

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