Research Scientist I
Posting ID: JP-002663242
Perform analytical method development, validation, and chemical analysis associated with drug products and material characterization including; LC and GC with and without MS detection, 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.
GC, LC, LC-MS, GC-MS, ICP-MS, pH, TOC, UV-VIS, FDA, GMP, Method Validation, Leachables, Extractables, ICH, GCP, USP, MassHunter
Top Skills Details:
GC,LC,LC-MS,GC-MS,ICP-MS, pH, TOC,UV-VIS, FDA, GMP, Method Validation, Leachables, Extractables
Additional Skills & Qualifications:
Bachelor 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.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072