Research Associate II - R&D, Stability Studies

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

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.

What will you be Doing !

• To provide support to the Stability Team in day to day technical and operational activities.
• Develop stability study designs for new product development and sustaining product projects.
• Without assistance, make sound technical recommendations regarding stability study designs for new product development and sustaining product projects that are more routine than not.
• Provide some analysis/redesign of key experimental procedures.
• Independently select techniques and procedures to solve problems within area of responsibility.
• Employ appropriate techniques/methods to successfully and independently execute routine assignments related to stability study design and development within negotiated deadlines. Identify alternative methods and technologies for improving existing or new products/processes.
• Maintain current/working knowledge of relevant QSRs and other regulatory requirements, such as the stability related ICH guidelines, for R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
• Recommend appropriate study designs, techniques, and processes for a specified sequence of tasks where needed, including the use of LIMS systems for electronic stability protocols.
• Contribute to technical feasibility analysis of complex.
• Demonstrate ability to apply technical theories and principles to projects within area of Expertise for nonroutine tasks. Analyse and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications.
• Evaluate results relative to product requirements, definitions and/or program goals.
• Providing technical rationale for expiration dating and label storage statement recommendations,
• Preparing regulatory submissions, responding to regulatory communications.
• Ensuring compliance related deliverables are completed on schedule and per plan.
• Independently plan and execute a series of stability study designs and/or technical tasks that may not be
• well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
• Play a lead role in the evaluation, selection and adaptation of various techniques/strategies, which accomplish business objectives such as quality and cycle time.
• Displays a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise.
• In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, can be able to provide expert advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.
• Maintain focus on meeting both external and internal customer expectations.
• Develop stability study designs for new product development and sustaining product projects.
• Contribute to technical feasibility analysis of complex research and design concepts.
• Evaluate results relative to product requirements, definitions and/or program goals.
• Providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications.
• Ensuring compliance related deliverables are completed on schedule and per plan.
• Collaboration with cross functional teams such as QA, M&Q, Regulatory, Quality control, and all the projects.
• Coordinate stake holders to progress the projects and internal activities in a right direction to achieve the organizational requirement.
• Maintain audit readiness and keep lab premises clean & tidy.
• To follow all the relevant cGxP and related regulations.
• Lead the analytical problem-solving efforts to meet urgent business needs.
• Focus on innovation, process improvement, and/or operational excellence initiatives.
• Independently plan, execute, and manage projects/programs that both span multiple disciplines and utilize established methods, techniques, or approaches.
• Implement new or improved techniques and procedures around specific tasks; write and implement SOP's. Implement research outlines for large scientific projects. Apply state of-the-art techniques in expertise to develop new or improved products. Able to handle the NCR/sNCR and Change controls.
• Drive/contribute to the harmonization of stability practices across Baxter/CRO sites as applicable

What will you Bring In:

• Master’s degree with 13 years GxP laboratory experience.
• Experience in Stability activities, Method transfer, Method development, Method validation, Method equivalency, Method verification and Regulatory queries handling.
• Planning and work allocation, assurance of the completeness of the activity for Stability studies of Finished Products (Solid dosage and Injectables).
• Responsible for initiation of Stability studies in LIMS, Review of Stability protocols and reports.
• Review of stability initiation documents and respective logbooks.
• End-to-end maintenance of Reference standards and distribution across global sites.
• Providing training to team members on procedures and processes.
• Maintenance of Stability chambers.
• Involving in Internal and External Audits and providing responses.
• Planning Photo stability, In Use, and Freeze-Thaw stability studies.
• Plan, conduct and review of Analytical method validation and transfer of analytical methods for drug products (Injectables).
• Review of test methods, SOP’s, specifications, method validation and transfer protocols & reports.
• Interpret test results, compare them to established specifications and make recommendations on data for release.
• Planning of Instrument Qualifications, Calibrations and Review of respective documents.
• Handling of out of specification (OOS), out of trend (OOT) investigations, laboratory Incidents, Deviations and Change controls.
• Result entry and approval in LabVantage LIMS.
• Providing training to team members about result entry, sample receipt, approval in LIMS.
• Author, reviewer and coordinator in Electronic Document Management System (EDMS), Documentum Software.
• Design and build Stability Protocols, reports and review of respective documents.
• Working with clients for regulatory queries, deficiencies related to analytical and quality control activities for regulatory submissions.
• Experience in coordinating with cross functional teams like QA, RA, PM, EAM and IT.
• Responsible for maintaining KPI and KQI for team.
• Performance evaluation of team members and providing feedback to them.
• Providing training to team members on analytical techniques and procedures.

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

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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