QC Analytical Method Development Scientist

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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.

QUALIFICATIONS AND REQUIREMENTS:

• 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.

• Experience supporting PET/SPECT radiotracers, sterile injectables, or radioactive drug products is preferred but not required.

• 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.

WORK ENVIRONMENT:

• Primarily laboratory-based with routine use of analytical instrumentation.

• Requires adherence to GMP, safety procedures, and PPE requirements.

• Occasional flexibility needed to support project deadlines and analytical troubleshooting

What We Offer:

• 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.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.