Research Scientist I
25212 W IL Route 120 Round Lk Bch, IL 60073 US
Research Scientist 1: Medication Delivery Analytical Strategies and Laboratories.
Perform analytical method development, validation, and chemical analysis associated with material characterization including; LC and GC with MS detection. May perform ICP-MS, and wet chemical techniques (titrations, pH, UV, and TOC). Perform validation of analytical methods for quantitative analysis. Interact with change control teams to gather and evaluate information from material suppliers. Specifically, this position is expected to:
- Independently execute analytical testing following written test procedures and study protocols, process and document results per GXP regulations, and review data for accuracy and completeness.
- Apply analytical separation and detection techniques for complex impurity identification/quantification.
- Design and execute method validation and transfer studies.
- Assess the technical feasibility of complex research and design concepts.
- Contribute to the analytical problem-solving efforts to meet urgent business needs.
- Collaborate with other functions such as project management, regulatory, formulation, engineering, manufacturing, and quality control in project teams.
- Collaborate with external partners to ensure successful execution of analytical testing and study designs.
- Maintain knowledge of relevant QSR and other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
- In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
- Maintain focus on meeting both external and internal customer expectations.
- Bachelors degree in relevant scientific discipline (chemistry, pharmaceutical sciences) with 5-7 years experience or Masters degree with 3-5 years experience or PhD with 0-3 years experience.
- Proficient at GC/MS and LC/MS analysis.
- Experienced with analytical method development, validation, and transfer in pharmaceutical regulated laboratories.
- Experience with extractables and leachables testing and Elemental Impurities is desired
- A good understanding of ICH, USP guidelines and cGxP practice.
- Familiarity and hands-on experience with HPLC, GC, UV, MassHuner and other analytical instruments and software.
- Ability to learn quickly and to solve problems in a timely manner using analytical chemistry skills.
- Possess relevant writing and computer skills.
- Ability to design experiments and draw meaningful conclusions from lab data.
- Experience in working in global cross-functional teams and project management is a plus.
- Quality oriented.
- Ability to adapt to changes and to work in a team environment.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.