Research Associate II – Stability
Overview
Baxter’s Research and Development teams work cross-functionally to innovate, develop, and introduce creative healthcare solutions that address patient needs globally. From scientists to engineers, Baxter R&D professionals contribute to products and technologies that save and sustain lives.
The Research Associate II – Stability will provide technical and operational support to the Stability Team and contribute to stability study design, execution, technical problem-solving, regulatory compliance, and cross-functional project activities.
Role Purpose
The primary responsibility of this position is to support stability-related activities for new product development and sustaining product projects. The role requires independent technical judgment, knowledge of stability science and cGxP requirements, effective experimental design, data evaluation, and collaboration with cross-functional stakeholders.
Key Responsibilities
Stability Study Design and Execution
Develop stability study designs for new product development and sustaining product projects.
Independently execute routine stability assignments using appropriate techniques and methodologies within agreed timelines.
Independently plan and execute stability studies and technical activities involving multiple variables, advanced techniques, or less-defined requirements.
Recommend appropriate study designs, techniques, and processes for defined sequences of technical tasks.
Use LIMS systems for the creation and management of electronic stability protocols.
Evaluate and adapt experimental procedures to improve existing or new products and processes.
Identify alternative methods and technologies to improve product performance, processes, quality, and cycle time.
Contribute to the technical feasibility assessment of complex products and research and design concepts.
Technical Analysis and Problem Solving
Provide sound technical recommendations for routine stability study designs with minimal assistance.
Analyze and redesign experimental procedures where required.
Independently select appropriate techniques and procedures to solve problems within the area of responsibility.
Apply scientific theories and technical principles to both routine and non-routine projects.
Analyze and determine appropriate solutions for non-routine experimental design and research problems with minimal supervision.
Accurately assess experimental results for validity, reliability, and conformance to specifications.
Evaluate study results against product requirements, definitions, specifications, and program objectives.
Lead analytical problem-solving efforts to address urgent business and project needs.
Provide technical input and rationale for complex stability-related decisions.
Expiration Dating and Regulatory Support
Provide technical rationale for expiration dating recommendations.
Provide technical rationale for label storage statement recommendations.
Support the preparation of regulatory submissions related to stability activities.
Respond to regulatory communications and provide appropriate technical information and supporting rationale.
Ensure stability and compliance-related deliverables are completed according to established plans and timelines.
Maintain current working knowledge of relevant Quality System Regulations (QSRs), ICH stability guidelines, cGxP requirements, and other applicable regulatory requirements.
Ensure research, data collection, analysis, documentation, and reporting activities comply with applicable regulations and internal procedures.
Participate in the generation, review, interpretation, adoption, and implementation of applicable regulations and guidance.
Cross-Functional Collaboration
Collaborate with cross-functional teams, including:
Quality Assurance (QA)
Manufacturing and Quality (M&Q)
Regulatory Affairs
Quality Control (QC)
Research and Development
Project and Program teams
Coordinate with stakeholders to ensure projects and internal activities progress effectively and meet organizational requirements.
Maintain focus on meeting internal and external customer expectations.
Demonstrate an understanding of theories, practices, and requirements across disciplines outside the primary area of expertise.
Provide technical support and guidance to project teams as required.
Compliance and Quality Systems
Follow all applicable cGxP requirements, regulations, guidelines, and internal procedures.
Ensure stability activities are performed in accordance with approved protocols, procedures, and quality requirements.
Handle Non-Conformance Reports (NCRs), significant Non-Conformance Reports (sNCRs), and Change Controls.
Ensure compliance-related activities and deliverables are completed on schedule and according to approved plans.
Support continuous improvement of stability processes and quality systems.
Innovation and Process Improvement
Identify opportunities for innovation, process improvement, and operational excellence.
Lead or participate in initiatives designed to improve quality, efficiency, cycle time, and technical capabilities.
Implement new or improved techniques and procedures for specific technical activities.
Develop, revise, and implement Standard Operating Procedures (SOPs).
Develop and implement research outlines for large scientific projects.
Apply state-of-the-art scientific and technical approaches within the area of expertise to develop new or improved products and processes.
Project and Program Management
Independently plan, execute, and manage projects or programs spanning multiple disciplines.
Use established scientific methods, techniques, and approaches to achieve project objectives.
Coordinate multiple stakeholders and technical activities to ensure successful project execution.
Manage assigned activities within negotiated timelines and agreed project requirements.
Take ownership of technical deliverables and drive activities toward successful completion.
Required Technical Capabilities
Strong knowledge of stability study design and execution.
Understanding of stability principles and applicable ICH guidelines.
Working knowledge of cGxP requirements and relevant regulatory expectations.
Ability to design and execute routine and non-routine experiments independently.
Strong analytical and scientific problem-solving capabilities.
Ability to interpret stability data and assess results against specifications and product requirements.
Experience with electronic systems such as LIMS for stability protocol management.
Understanding of expiration dating and storage condition recommendations.
Ability to prepare technical documentation and provide regulatory support.
Experience handling NCRs, sNCRs, and Change Controls.
Ability to develop and implement SOPs and improved technical procedures.
Strong project coordination and stakeholder management skills.
Ability to work effectively in a cross-functional R&D environment.
Success Profile
Baxter looks for R&D professionals who demonstrate the following attributes:
Courage
Action orientation
Collaboration
Innovation
Ability to manage ambiguity
Results orientation
Ownership and accountability
Technical problem-solving capability
Customer focus
Role Expectations
The Research Associate II – Stability is expected to work with a high degree of independence while maintaining strong collaboration with cross-functional teams. The individual should be capable of making sound technical decisions, managing multiple stability activities, addressing non-routine technical challenges, and ensuring that all activities comply with applicable quality and regulatory requirements.
The position also requires a proactive approach toward innovation, continuous improvement, operational excellence, and the development of new or improved scientific and technical approaches.
About Baxter
Baxter is committed to its mission to Save and Sustain Lives. The organization focuses on developing healthcare products and solutions that make a meaningful difference to patients and healthcare professionals worldwide.
Baxter promotes a culture built around courage, trust, collaboration, ownership, and accountability, providing employees with opportunities to contribute to meaningful work and professional development.
Employee Benefits and Support
Support for parents
Continuing education and professional development
Employee health and well-being benefits
Paid time off
Two days per year for volunteering
Equal Employment Opportunity
Baxter is an equal opportunity employer. Qualified applicants are considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability or handicap status, or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to providing reasonable accommodations to individuals with disabilities globally. Candidates requiring an accommodation during any part of the application or interview process may contact Baxter through the accommodation process provided in the original job posting.
Recruitment Fraud Notice
Baxter has identified incidents of employment scams in which fraudulent individuals impersonate Baxter employees, recruiters, or other representatives to obtain personal or financial information.
Candidates should exercise caution when responding to recruitment communications and should refer to Baxter’s official Recruitment Fraud Notice for information on identifying and protecting themselves from employment-related scams.
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