Clark & Enersen · 2 months ago
QC Analytical Method Development Scientist
Indianapolis, IN, US
Full-time, Part-time
Onsite
Mid, Senior Level
$85K/yr - $95K/yr
3+ years expClark & Enersen is seeking an experienced QC Analytical Method Development Scientist to join their ELIQUENT Engineering team. The role involves designing, developing, optimizing, and validating analytical methods for pharmaceutical product development while ensuring compliance with GMP/GLP requirements and ICH guidelines.
Consulting
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
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
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 is preferred but not required
Familiarity with Empower and GMP documentation systems
Benefits
Health, dental, vision, and life insurance
401(k) plan with employer match
Generous paid time off policy
Additional perks
Company
Clark & Enersen
Clark & Enersen was founded in 1946 in by Architect Kenneth B. Clark and Landscape Architect Lawrence A.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase