Research Associate II RD Characterization
Research Associate II RD Characterization
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Job Description
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. 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 liveswhere your purpose accelerates our mission.
Research Associate II Nitrosamines (Characterization Team)
Baxter Pharmaceuticals R&D is seeking a highly motivated scientist with proven expertise in liquid chromatography and mass spectrometry to join its Characterization team. As a key contributor within the Pharmaceuticals Global Business Unit the successful candidate will oversee and apply stateoftheart technologies in LCMS and GCMS in support of new and existing pharmaceutical products. The scientist in this role will support Nitrosamine studies extractables and leachable studies using mass spectrometrybased approaches to identify nitrosamines potential leachables from container extracts and develop and validate LC/MS methods to quantify leachable compounds in finished drug product solutions. The candidate is expected to work independently in the laboratory to direct studies conduct independent experiments and generate and interpret data to solve challenging analytical problems.
What youll be doing
- Perform chemical extractions of container closure systems and drug product solutions in the laboratory.
- Apply stateoftheart mass spectrometrybased approaches to solve challenging problems. Develop and validate novel mass spectrometrybased analytical methods.
- Independently plan execute and manage projects/programs that both span multiple disciplines and utilize established methods techniques or approaches.
- Approve technical feasibility of complex design concepts within area of expertise; advise management regarding appropriate action.
- Interpret data evaluate analytical results identify trends/exceptions relative to product requirements definitions and/or project goals.
- Reach conclusions based on research analysis and incorporate recommendations into larger projects.
- Share research outcomes and methodology with team members and other divisional personnel.
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development to ensure compliance in all research data collection and reporting activities.
- Maintain an indepth knowledge and understanding of GxP and related regulations and guidance. Be able to provide expert insights into such regulations so as to facilitate efficient product registration. Be an active participant in the generation review adoption and interpretation of such regulations.
What youll bring
- Masters degree with at least 812 years or PhD with 67 years in relevant discipline required.
- Must have formal training in mass spectrometry. Must be skilled in carrying out sophisticated mass spectrometric experiments such as accurate mass and MS/MS and in the interpretation of mass spectrometric data.
- Must have good knowledge of organic chemistry and other analytical disciplines such as chromatography NMR IR etc. Possess skills or demonstrated scientific background for the development of the necessary skills for the elucidation of unknown compound structure using a multidisciplinary approach.
- Experience in Nitrosamine E&L testing/study design environmental chemistry testing and/or trace organic analysis preferred.
- Experience with complex method development and validation particularly for quantitative LC/MS methods preferred.
- Must be able to able to carry out strategy and vision set by upper management and be able to communicate the vision to more junior associates.
- Ability to make routine and some less routine decisions independently.
- Can effectively communicate with internal and external partners.
- Experience working in a regulated pharmaceutical environment (e.g. cGXP) preferred.
- Ability to learn quickly and to tackle problems in a timely manner using analytical chemistry skills.
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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Required Experience:
IC
Employment Type
Full-Time
