Research Scientist I - E&L Chemical Characterization
Baxter
- Round Lake, IL
- $104,000-143,000 per year
- Permanent
- Full-time
- Performs analytical chemistry to characterize extractables and leachables from drug products packaging and from medical devices. Utilizes LC/MS, GC/MS, and/or ICP/MS to chemically characterize test articles for E&L studies. Efficiently and effectively manages large and complex datasets and concisely reports findings.
- Conducts research or designs strategies to achieve the technical vision for a new or improved product/process/method or to prove a new theory, applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise.
- Provides assistance and interpretation of project results to team members and other business unit personnel.
- Studies, designs and recommendations reflect impact by and to diverse disciplines.
- Preparation and analysis of samples for trace level organic compounds utilizing state-of-the-art GC/MS and LC/MS instrumentation. Perform structural elucidation and quantitative analysis of chemical compounds identified.
- Efficiently execute programs in such a way as to reduce cycle-time while meeting all regulatory and quality requirements under general direction. Independently plan, execute and manage projects/programs that both span multiple disciplines and utilize established methods, techniques or approaches.
- May be sought out by other teams and individuals to offer technical advice; may act as coach, mentor, and reach conclusions based on research analysis and incorporate recommendations into larger projects. Apply advanced techniques to solving difficult problems. Approve technical feasibility of complex design concepts within area of expertise; advise management regarding appropriate action.
- Generate innovative solutions to complex problems through the use of multiple disciplines and technical principles. Create innovative products/processes/methods through novel combinations of expertise within the organization.
- Develop new or improved techniques and procedures around specific tasks; write and implement SOP's. Develop research outlines for large scientific projects. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
- As a good team player, share research outcomes, methodology and cycle-time reduction methods with team members and other divisional personnel.
- Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
- Authors articles in journals, apply for patents and contribute to scientific literature and conferences.
- In-depth knowledge and understanding of GxP and related regulations and guidance and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
- May supervise and direct Research Associates.
- Support global footprint expansion and drive applicable implementation.
- Bachelor's degree in a scientific discipline required with at least 8+ years of relevant experience, MS with at least 5 +years, or PhD with at least 0-2 years of relevant experience. QSR research experience is essential and GMP experience useful. For Research Associate III level looking for 5+ years of experience.
- Lab experience includes research in GMP/QSR environment; leadership of technical teams, and project management experience is desirable.
- Comprehensive experience in Extractables and Leachables testing for pharmaceutical products. Functional knowledge of requirements outlined in USP
and
1664
as well as ISO 10993-18. * Requires excellent written and oral communication skills. The incumbent has daily contact with a variety of research personnel, technical peers and appropriate managerial personnel, as well as frequent contact with customers, clients, vendors and suppliers. Must be able to accurately and effectively convey recommendations, data, observations, results and problems to co-workers and customers
- Research lab experience includes research in GMP/QSR environment, cross-functional teamwork, and independent experimentation in method development and validation.
- Understanding of quality requirements of laboratory operations under regulated environments.