Ahmedabad, Gujarat
18 hours ago
Research Associate II, R&D-ADL (Method Transfer)

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.

Responsible for Analytical Method Transfer activity at Baxter and Non-Baxter Manufacturing sitesPreparation of method transfer and method verification protocol and reportReview of method transfer and method verification protocol and reportReview of raw data generated during method transferReview of API DMF, specification and Method of analysis for API, FP, Excipient and Packaging materials in close co-ordination with CFTs/CMOs.Trouble shooting of the Analytical method for HPLC, GC, IC, ICPMS, Potentiometric techniqueMethod validation of API, excipients and Finished product for regulatory markets; US and EuropeReview of Compendial changes, their assessment and implementation at CMOs and plantReview of CMOs change control and approvalCollaborate with other functions such as project management, regulatory, formulation, manufacturing, and quality control in project teamsCollaborate with Baxter external partners to ensure successful execution of Method transfer and analytical testingResponsible for initiating the Quality Elements like Change and to complete the related tasks with close collaboration with CFT`s

Qualificaiton

Master’s degree with 10-12 years GxP laboratory/analytical experienceCommunication skills to build relationships across functional and geographical boundaries and present technical concepts to technical and non-technical teamsWriting and computer skills relevant to recording and reviewing of protocols, reports, and presentations to communicate with partners and team membersExperience with leading large analytical projects and analytical method validation and transferA good understanding of ICH, EMEA, EDQM, ANVISA, FDA and compendia (USP/EP/BP)Experience of working with global cross-functional teams and project management is a plus

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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