Senior Scientist 3, Analytical Chemist
Parexel International Corporation
Senior Scientist 2-3 Bayer (Morristown, NJ)
Description The Senior Scientist 3 (Analytical Development) supports analytical development and product development.
A Bachelor’s degree in Chemistry or Science, with minimum 6 years of proven experience. A Master’s degree with minimum 4 years of proven experience is preferred.
Required Skills and Experience
Must have QC or R&D experience in pharmaceutical industry
Specific Hand-on experience with Waters & Agilent HPLC / UPLC and dissolution apparatus (USP Type 1 and 2)
Understands fundamental analytical chemistry and chromatography
. Able to troubleshoot testing and/or analytical method related issues. Understands follows GMP / SOP requirements
Familiar with analytical laboratory documentation practices Expertise in Waters Empower3 CDS.
Expertise in MS Office, such as Word, Excel, and PowerPoint.
Good communication and interpersonal skills
This individual must be highly motivated, have a positive “can-do” attitude and the ability to work in a fast-paced environment as a collaborative team player
Practical knowledge and experience with application of analytical method development and method validation activities. Responsibilities
Performs extensive laboratory work to support pre-formulation development, formulation development, technology transfer activities, clinical trials, and evaluation of product performance and stability.
Conduct analytical method development, method validation and transfer
Perform analytical laboratory work to support product development
Accurately and timely document the experiments and results into the notebooks, ELN and LIMS (if required)
With minimum supervision, manages projects to ensure all tests are completed in time, results are accurate, and all activities are documented. Effectively communicates to all stakeholders the analytical activities and findings.
Follow SOPs/OIs and analytical laboratory practices to ensure the work quality and compliance
Write the analytical methods, specifications, method validation reports, experimental reports, and SOPs/OIs
Perform GMP comprehensive review of analytical activities such as but not limited to method development, method validations, method transfer, testing of analytical product development batches, process optimization batches, stability submission batches and Instrument technical records
Interact with analyst on the data review to recommend appropriate corrections / modifications / improvements needed to build consistency with respect to documentation practice guideline
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