Research & Development - Scientist II

V R Della InfotechCincinnati, OH
Onsite

About The Position

Support pharmaceutical development and manufacturing through analytical testing, method development and validation, data review, and laboratory troubleshooting. The role contributes to high-quality, compliant analytical work and effective delivery of project objectives within the Cincinnati Pharmaceutical Services Group.

Requirements

  • Bachelor's degree in Chemistry, Biochemistry, or another technical/scientific field or equivalent with 2-3 years of GMP and regulatory experience.
  • Experience performing chemical testing using chromatographic, spectroscopic, or other analytical techniques.
  • Pharmaceutical industry experience required.
  • HPLC/UPLC, including assay and related substances required.
  • GC and GCHS; chromatographic troubleshooting.
  • Dissolution testing; oral solid dosage (OSD) and ARS experience required.
  • Method validation, including repeatability, intermediate precision, filter studies, linearity, accuracy, and solution stability.
  • Working knowledge of chemistry, analytical instrumentation, and pharmaceutical quality/regulatory requirements.
  • Strong written and verbal communication and interpersonal skills.
  • Organized, diligent, and effective at problem-solving.
  • Customer-focused with a commitment to quality, timely delivery, and continuous improvement.
  • Proactively identifies ideas and solutions that strengthen team and site performance.

Nice To Haves

  • Empower experience preferred.

Responsibilities

  • Perform routine chemical and physical testing of pharmaceutical finished products and stability samples using chromatographic, spectroscopic, dissolution, and other analytical techniques.
  • Develop analytical methods and participate in validation of methods for pharmaceutical raw materials and finished products.
  • Write and execute validation protocols in accordance with regulatory requirements and approved laboratory procedures.
  • Process, review, interpret, document, and report analytical data; communicate results clearly to internal teams and external clients and make data-based recommendations.
  • Maintain and troubleshoot analytical instrumentation and support implementation of new methods and processes.
  • Manage assigned project tasks with minimal supervision, ensuring deliverables are completed and next steps are clearly identified.
  • Perform all work in compliance with SOPs, GMPs, GLPs, and applicable safety requirements.
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