Research Associate

Job Description

Research Associate IIIApply Now Save JobThis is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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.Job Summary Job Title Research Associate IIILocation Syngene, Bangalore Shift General The Renal Solutions and Containers - Analytical Chemistry and Stability team supports Renal Care and Acute Therapy R&D projects. We now have a vacancy for a Research Associate III in Bengaluru to represent Renal Solutions and Containers as a Stability Subject Matter Expert.The successful candidate would apply sound chemistry and stability planning expertise to identify and determine stability indicating characteristics. The effective integration of chemistry and stability enables establishment of shelf life for new and existing products manufactured for the expanding markets. The Stability Subject Matter Expert designs strategies and makes recommendations that are non-routine to address technical, regulatory, and business requirements. Job Responsibilities:

• Represent R&D Stability on project teams as a key part of the project teams goals and success.
• Design and execute stability strategy plans for exploratory, new product development, and sustaining projects.
• Design GMP stability studies used to establish expiration dating for new product development.
• Contribute to development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key stakeholders.
• Contribute to stability assessments and requirements for new product or product changes.
• Ensure the right methods and specifications are available for stability, compatibility and release testing. Ensure that the methods are appropriate for the product design over shelf life.
• Demonstrate the ability to identify risks, issues, and opportunities.
• Identify opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.
• Interact with manufacturing facilities to obtain information related to test methods and specifications.
• Author, review and verify technical data, protocols and reports.
• Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, data entry and review.
• Participate in investigations that correspond to atypical or out-of-specification/out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
• Effectively plan, coordinate and track the progress of multiple Stability related projects, budgets, and activities working with global teams and CROs as applicable
• Contribute to and/or take lead author role for stability sections intended for submission to regulatory authorities. Uses computerized system to retrieve, evaluate, summarize data for reporting.
• Coach and mentor junior members working in analytical methods development and stability.

Qualifications

• Bachelor s degree in a relevant scientific discipline with 9 13 years experience.
• Master s degree with 7-12 years, or PhD with 4-8 years experience in relevant discipline is preferred.

Skills

• Excellent English verbal and written communication skills.
• Ability to organize complex information and demonstrated attention to detail.
• Without assistance, make sound technical recommendations.
• Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
• Experience working with complex databases.
• Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.
• Good technical writing skills.
• Possess mastery of analytical chemistry including theoretical knowledge and practical experience.
• Possess understanding of manufacturing documents.
• Possess strong time management skills.
• Ability to work well in a collaborative team environment.
• Willingness to work across multiple time zones.
• Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Functional understanding of FDA, ISO and Quality system

Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.028951Apply Now Save Job,

Keyskills :
acquisitionsbasicbudgetingcash flow analysiscontact managementnew product developmenttest dataproject teamsproduct designtime managementtechnical skillsstability studies