Job Title: Research Scientist I
- Under direction of senior scientific staff, create innovative products/ processes/methods through novel combinations of expertise within the stability organization to ensure successful execution of stability batch production and testing across Baxter manufacturing sites and with external partners.
- 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 the stability area; advise management regarding appropriate action regarding study design and test strategy selection.
- Independently plan, execute and manage projects/programs that both span multiple disciplines and utilize established methods, techniques or approaches.
- Implement new or improved techniques and procedures around specific tasks; write and implement SOP’s. Implement research outlines for large scientific projects. Apply state-of-the-art techniques in the stability area to develop new or improved products and define product expiration dates.
- Shares research outcomes, methodology and cycle-time reduction methods with team members and other divisional personnel, implementing identified improvements across Baxter sites.
- 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 related to product stability.
- In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations. Provide leadership in meeting standards for preparation of regulatory submissions, responses to regulatory bodies, and pre-approval site inspections for Baxter products tested.
- May supervise and direct Research Associates.
- Bachelor of Science degree with 10 years, chemistry or pharmaceutical sciences preferred. Master’s degree with 5-7 years, or Ph.D. with 0-2 years of GxP laboratory experience.
- A good understanding of ICH and cGxP practice.
- Writing and computer skills relevant to recording original data as well as creating protocols, reports, and presentations to communicate with partners and team members.
- The ability to energetically attack a problem and synthesize the results into a clear and logical summary in a timely manner is critical.
- Communication skills to build relationships across functional and geographical boundaries and present technical concepts to technical and non-technical teams.
- Comfort with risk and ambiguity, ability to negotiate critical timelines for analysis in emergency situations.
- Personal responsibility and independent ownership of analysis and results.
- Ability to adapt to changes and to work in a team environment as well as delegate effectively to junior team members.