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ELIQUENT Life Sciences · 1 month ago

QC Analytical Method Development Scientist

Indianapolis, IN, US

Full-time, Part-time

Hybrid

Mid, Senior Level

$45/hr - $50/hr

3+ years exp

ELIQUENT Life Sciences is seeking an experienced QC Analytical Method Development Scientist to join their team in Indianapolis. This role focuses on supporting pharmaceutical product development through the design, development, optimization, and validation of analytical methods, ensuring compliance with GMP/GLP requirements and ICH guidelines.

ConsultingMedical DeviceProfessional Services

H1B Sponsor Likely

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

Qualification

HPLC/UPLCLC–MSGMP compliance21 CFR Part 212ICH guidelinesAnalytical problem-solvingTechnical writingCommunication skillsProject management

Required

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

Preferred

Experience supporting PET/SPECT radiotracers, sterile injectables, or radioactive drug products

Benefits

Health, dental, vision, and life insurance

A 401(k) plan with employer match

A generous paid time off policy

Additional perks

Company

ELIQUENT Life Sciences

ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.

Washington, District of Columbia, USA

501-1000 employees

https://eliquent.com

H1B Sponsorship

ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (29)

2024 (3)