Senior Scientist 2, Analytical Chemist

Parexel International Corporation

Multiple Locations

Senior Scientist 2-3 Bayer (Morristown, NJ)

Description The Senior Scientist 3 (Analytical Development) supports analytical development and product development.

Qualifications

 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


2022-09-20 00:05:17


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