Analytical Chemist

The Kidney Care R&D - Analytical Chemistry team currently has an opening for an experienced Analytical Chemist. The successful candidate will effectively contribute solid technical knowledge to a variety of projects within the relevant discipline with minimal assistance and display basic technical understanding of related disciplines, including the support of the transfer of Kidney Care R&D from the Round Lake site to the new Minnesota site.

Essential Duties and Responsibilities:

1. Provide support for the transfer of Kidney Care R&D from the Round Lake Campus to the new Minnesota site. This support may include:

o Conducting routine/non-routine research

o Designing experiments with minimal assistance

o Performing analytical method validations, transfers and oversight of work to CRO (Contract Research Organization)

o Performing instrument qualifications and validations

o Acting as author or study director for protocols and reports

o Ensuring all laboratory items at the Kidney Care R&D Round Lake site are ready for transfer to the new Minnesota site

2. Without assistance, make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.

3. Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes.

4. Collaborate with other functions such as project management, regulatory, formulation, manufacturing, and quality control in project teams.

5. Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.

6. Contribute to technical feasibility analysis of complex research and design concepts.

7. Have a working knowledge and understanding of GxP and related regulations and guidance.

8. Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks.

o Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance.

o Accurately assess results for validity and conformance to specifications.

Qualifications:

• Understand data management, ability to manage/perform data migration.

• Familiar with laboratory start-up

• Possess relevant laboratory/technical, writing, and computer skills.

• Expertise and hands-on experience with NMR, HPLC, GC, UV, Empower and other analytical instruments and software.

• A detailed understanding of ICH, USP guidelines and cGxP practices.

• Experience with analytical method development, validation and transfer.

• Demonstrates flexibility and can shift gears comfortably.

• Ability to objectively assess, organize, and clearly communicate complex information to the project team.

• Interpret laboratory data and make recommendations to resolve technical challenges.

• Appropriately prioritize assignments to meet project schedules.

• Quality oriented.

Education and/or Experience:

Master’s degree with 1-2 years or Bachelor’s 2-4 years of related experience or advanced degree.