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Summary
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
The Renal Solutions Analytical Chemistry and Stability teams support Renal R&D projects as well as commercial products across Baxter’s business units. We now have a vacancy for a Research Associate II to engage in cross-functional Analytical Lead and Stability Operations activities. The successful candidate would apply sound chemistry and appropriate analytical methodology with 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.
Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
- Supports design and execution of the analytical design and stability strategy plans for exploratory, new product development, and sustaining projects.
- Supports creation and implementation of analytical plan and stability plan including analytical chemistry assessments and gap assessments.
- Support the analytical method transfers to manufacturing plants, CRO and other R&D centers.
- Assess and oversee the qualification of the analytical methods and specifications. Assures the right methods and specifications are available for the stability, compatibility and release testing. Ensure that the methods are appropriate for the product design over shelf life.
- Assures that the analytical test designs are fit for purpose and in sync with the business needs. Ability to identify risk issues and opportunities.
- Collaborates across functional team of Analytical and Stability experts with internal / external labs / suppliers.
- Interact with manufacturing facilities to obtain information related to test methods and specifications.
- Author, review and verify technical data, protocols and reports.
- Coordinate across Analytical Lead, manufacturing plants, and Stability Planners.
- Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, data entry and review.
- Support investigations in complex analytical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and methodology related issues. Leverages critical thinking skills to find the right solutions for the business above functional considerations
- Effectively plans, coordinates and tracks the progress of multiple Analytical and Stability related projects, budgets, and activities.
- Contribute to Analytical and Stability sections intended for submission to regulatory authorities. Use computerized system to retrieve, evaluate, summarize data for reporting.
Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
- Ability to organize complex information and demonstrate 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 systems.
Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
- Bachelor’s degree with 2-4 years’ relevant experience or Masters in chemistry or chemistry-related field.
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.
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Reasonable Accommodations
Baxter 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.
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