Job DescriptionHow You'll Contribute:This position is within the Analytical Technologies of the Applied Research department working on implementing and managing analytical activities to support new product development, formulations, early-stage and late-stage clinical studies.
The position will focus on development, validation, and transfer of analytical methods for drug product and drug substance as well as performing analytical testing for release and stability studies, evaluating data and conducting trending analysis. The position will work effectively and collaboratively with cross-functional groups and is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines.
What You'll Do:- Utilizes a strong scientific background to develop and validate methods in an analytical laboratory under supervision
- Operates, maintains and troubleshoots analytical equipment such as HPLC/UPLC, FTIR, UV-Vis Spectrophotometer etc. while ensuring compliance to GLP/GMP standards.
- Troubleshoots and provides analytical support for investigations studies and solves analytical issues in timely manner, ensures generation of high-quality scientific data. Evaluates and interprets analytical results from release and stability studies and provides scientific conclusions.
- Performs bench-level drug product stability testing and release of test articles, generating accurate and precise data using advanced analytical technologies.
- Has hands-on and direct expertise in analytical methodologies used for the drug release, potency, stability, and impurity testing. Demonstrate method suitability for applications to drug product development.
- Prepares experimental protocols and well written technical reports in support of regulatory submissions.
- Proactively develops and maintains knowledge in current analytical sciences and investigates new technology and recommends innovative techniques to the team. Maintain strong working knowledge of ISO/GLP/GMP compliance.
- Plus, other duties as assigned by management
How You'll Get There:- Strong scientific background and hands-on knowledge of chemical analysis principles, chromatographic theories and technologies.
- Working knowledge of a wide range of analytical methods (i.e., HPLC, UPLC, GC, dissolution, LC-MS, UV/Vis), and other common analytical techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product.
- Ability to troubleshoot analytical related problems at all stages of development.
- Experience in oversight of stability studies and conducting trend analysis.
- Experience working in a cGMP analytical laboratory is preferred.
- Demonstrated ability to learn (new technologies, methodologies etc.)
- Strong ability and knowledge to develop, validate and transfer analytical methods.
- Excellent verbal communication, strong writing skills, and being detail and result oriented are important attributes.
- Working knowledge of drug development and drug substance and drug product regulations, including relevant USP, FDA and ICH regulatory requirements and guidance documents for analytical testing and stability assessments.
- Requires a Bachelor's degree in a Scientific discipline, such as analytical chemistry, pharmaceutical chemistry or pharmaceutical sciences and a minimum of 2-5 years related experience, or a Master's degree and a minimum of 1-2 years of pharmaceutical industry experience
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