Assoc Scientist II

This is where  your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

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Summary : This section focuses on the main purpose of the job in one to four sentences. Extractables and Leachables Subject Matter Experts (SMEs) within the New Product Development (NPD) organization take ownership of the E&L strategy for a diverse product portfolio within the Pharmaceuticals Global Business Unit (GBU), interacting with numerous global cross-functional internal partners (Regulatory Affairs, Pre-Clinical Toxicologists, Device Engineers, Formulation Scientists & Quality) as projects progress from concept to launch and on-market support. We now have a vacancy for an analytical scientist with proven expertise in chromatographic and mass spectroscopic techniques, applied within a highly regulated environment. The successful candidate will be recognized for their strong analytical expertise and awareness of E&L, taking on the role of an Extractables / Leachables Subject Matter Expert (SME) within the Pharma E&L team. In this role, the successful candidate will have responsibility for the oversight of all project related activity, managing key stakeholders and customers and collaborating with a multidisciplinary team of subject matter experts to develop, execute and summarize the E&L strategy within global regulatory dossiers. The data generated plays a pivotal role in demonstrating the safety of the materials used to manufacture, package and deliver drug products within the Pharma portfolio.

Essential Duties and Responsibilities : This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

• Execution of a diverse range of projects of high complexity
• Applies practical and theoretical expertise in chromatographic (GC and LC), spectroscopic and mass spectrometry techniques to develop and execute non-routine experimental protocols
• Interfaces with internal partners to interpret complex analytical data; including quantitation, structural elucidation and toxicological assessment
• Authors and reviews a variety of technical reports, protocols, and regulatory dossiers
• Data management and organization

Qualifications : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and / or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Education

and / or

Experience : Include the education and experience that is necessary to perform the job satisfactorily.

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

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Skills Required

Data Management, mass spectrometry