- Provide support for the transfer of Kidney Care RD from the Round Lake Campus to the new Minnesota site. This support may include:
- Conducting routine/non-routine research
- Designing experiments with minimal assistance
- Performing analytical method validations transfers and oversight of work to CRO Contract Research Organization
- Performing instrument qualifications and validations
- Acting as author or study director for protocols and reports
- Ensuring all laboratory items at the Kidney Care RD Round Lake site are ready for transfer to the new Minnesota site
- 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.
- 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.
- Collaborate with other functions such as project management regulatory formulation manufacturing and quality control in project teams.
- Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to RD product development design and safety to ensure compliance in all research data collection and reporting activities.
- Contribute to technical feasibility analysis of complex research and design concepts.
- Have a working knowledge and understanding of GxP and related regulations and guidance.
- Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks.
- Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance.
- Accurately assess results for validity and conformance to specifications.
- 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.
- Masters degree with 1-2 years or Bachelors 2-4 years of related experience or advanced degree.
- HPLC
- GC
- GMP/GLP lab
- Pharma or Med device ideally
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
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Research Associate Scientific II - Grayslake, United States - Actalent
Description
Description:
The Kidney Care RD - 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 RD from the Round Lake site to the new Minnesota site.
Essential Duties and Responsibilities:
Qualifications:
Education and/or Experience:
Skills & Qualifications:
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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