Research Scientist I
Req #: 180004FO_en
Location: Bangalore, KA IN
Job Category: Research and Development
Date Posted: 4/12/2018 7:18:37 AM
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis;
sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy
automation, software and services. The company’s global footprint and the critical nature of its products and services
play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide
are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare
innovations that enable patient care.
This Research Scientist I position will lead the Stability Team in the following day to day technical and operational activities: stability planning for new product development and to sustain current product line, directing R&D and commercial stability studies executed in Baxter facilities and at Contract Research Organizations, providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications, and ensuring compliance related deliverables are completed on schedule and per plan. Specifically, this position is expected to:
- 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.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific
innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and
technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing
creative collaborations that bring our mission to life for patients every day.
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, disability/handicap status or any other
legally protected characteristic.