Research Associate II, Stability

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Your Role at Baxter:

At Baxter you will lead the design and execution of stability studies supporting new product development and sustaining product initiatives. You will provide scientific and regulatory guidance for stability programs including shelf-life and storage condition recommendations. Working closely with cross-functional teams you will ensure compliance with global regulatory requirements and project timelines.

What youll be doing:

• Develop and execute stability study designs for new product development and sustaining product projects.
• Provide scientific justification for shelf-life expiration dating and storage condition recommendations.
• Lead stability-related technical investigations and analytical problem-solving activities.
• Prepare and support regulatory submissions and responses to health authority inquiries.
• Ensure compliance with ICH (International Council for Harmonisation) stability guidelines cGxP QSRs and internal quality requirements.
• Collaborate with QA QC Regulatory Affairs Manufacturing and R&D teams to support project objectives.
• Utilize LIMS and electronic stability systems for protocol creation and study management.
• Drive continuous improvement innovation and operational excellence initiatives.
• Develop and implement SOPs scientific procedures and best practices.
• Independently manage multiple stability projects and deliverables within established timelines.

What youll bring:

• or equivalent degree in Pharmaceutical Sciences or related discipline.
• 8 years of experience in Stability Studies Pharmaceutical Product Development or related R&D functions.

• Strong knowledge of stability study design execution and data interpretation.
• In-depth understanding of ICH Stability Guidelines cGxP requirements QSRs and global regulatory expectations.
• Experience supporting expiration dating shelf-life determination and storage condition recommendations.
• Hands-on experience with LIMS and electronic stability management systems.

• Strong analytical and scientific problem-solving skills.
• Ability to independently manage complex technical projects.
• Excellent technical writing and regulatory documentation skills.
• Effective stakeholder management and cross-functional collaboration abilities.
• Demonstrated capability to influence technical decisions and drive process improvements.

• Experience with global regulatory submissions and health authority interactions.
• Experience leading operational excellence and continuous improvement initiatives.
• Broad understanding of pharmaceutical development manufacturing and quality systems.

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.

Reasonable Accommodations

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