QC Analytical Method Development Scientist

Eliquent Life Sciences, Inc-posted 27 days ago
Full-time • Mid Level
Onsite • Indianapolis, IN
251-500 employees
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We at ELIQUENT are looking for an experienced QC Analytical Method Development Scientist to immediately join our ELIQUENT Engineering - Chicago team. The Analytical Method Development Scientist supports pharmaceutical product development by designing, developing, optimizing, and validating analytical methods used for characterization, in-process control, release testing, and stability studies. This role ensures all analytical work complies with GMP/GLP requirements and ICH guidelines.

  • Develop and optimize analytical methods for small-molecule drug substances, drug products, excipients, and in-process samples.
  • Utilize pharma-relevant techniques such as HPLC/UPLC, GC, LC–MS, dissolution testing, UV-Vis, FTIR, and compendial methods.
  • Assess method performance (e.g., selectivity, sensitivity, linearity, robustness) and generate scientifically sound rationale for method conditions.
  • Troubleshoot analytical methods and instrumentation issues to ensure reliable performance in a GMP setting.
  • Design and execute validation protocols with any of the following 21 CFR Part 212, USP /, ICH Q2(R2), and FDA guidance.
  • Prepare method validation reports, risk assessments, and technical justifications.
  • Perform statistical analysis of method performance using pharma-appropriate tools.
  • Maintain accurate and compliant GMP documentation consistent with ALCOA+ principles.
  • Assist with the development of method SOPs.
  • Participate in project teams to ensure analytical readiness for clinical and commercial production.
  • Participate in failure investigations, root cause analyses, and CAPA activities involving analytical methods or results.
  • Bachelor’s in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.
  • 3–7+ years of experience in pharmaceutical analytical development, method validation, or QC in a GMP-regulated environment.
  • Strong hands-on experience with HPLC/UPLC, GC, LC–MS, UV-Vis, FTIR, dissolution, and compendial methods.
  • Knowledge of 21 CFR Part 212, 21 CFR Part 211, USP, and ICH guidelines
  • Familiarity with Empower and GMP documentation systems.
  • Strong analytical problem-solving skills.
  • Excellent technical writing and communication abilities.
  • Ability to manage multiple development projects and work independently in a fast-paced pharma environment.
  • Experience supporting PET/SPECT radiotracers, sterile injectables, or radioactive drug products is preferred but not required.
  • Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
  • Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
  • Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.
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