Baxter is looking to solve problems related to healthcare delivery and product development by hiring a Research Scientist I - Chemical Characterization to contribute to their R&D organization.
Requirements
- Required knowledge and demonstrated experience of analytical chemistry with relevant laboratory skills (hands-on experience with wet chemical techniques and instrumental analysis including GC/MS/FID MS).
- Experienced with analytical method development, validation, and transfer.
- Possesses a good understanding of ICH, USP guidelines and cGxP practice.
- Experience with analytical instrument software systems such as MassHunter, Empower, Chromeleon, E-noval.
- Ability to learn quickly and to solve problems in a timely manner using critical thinking and analytical chemistry skills.
- Designs experiments and draws meaningful conclusions from lab data in addition to critically review peers’ work.
- Demonstrates quality and detail-oriented work.
Responsibilities
- Design and execute extractables and leachables, method development, validation, and transfer studies.
- Conduct impurities studies (routine and non-routine) by performing chemical analysis utilizing LC, GC, and/or ICP with various detections including MS and associated wet chemistry and sample preparation techniques.
- Participate in investigations that correspond to atypical or out-of-specification/out-of-trend results. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
- Create, update, and maintain equipment and analytical procedures.
- Maintain knowledge of and demonstrate adherence to relevant Quality System Regulations and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. This applies to governmental and international industry requirements, procedures, regulations, and standards e.g., related to method validation (USP, ICH).
- Leverage operational excellence in the execution of laboratory activities.
- Evaluate analytical results, identify trends, exceptions, and interpretation of results relative to product requirements, definitions and/or project goals.
Other
- Bachelors in Chemistry or equivalent with 5+ years of experience, Masters with 3+ years or PhD with 0+ years..
- Communicate clearly with management, peers, cross-functional teammates, and non-technical audiences by openly sharing project status and hurdles and seeking input from other team members.
- Provides and accepts critical feedback from others in a constructive manner.
- Adapts to changes and has an Agile mindset.
- Works in a team environment and demonstrates an inclusive attitude.
