Senior Quality Laboratory Analyst

JOB SUMMARY The Senior Quality Laboratory Analyst (Analytical Chemist) is a pivotal role dedicated to ensuring the quality, purity, and regulatory compliance of pharmaceutical products spanning Small Molecules (Solid Dose) to Advanced Therapies. Operating within a rigorous cGMP environment, this role is responsible for executing complex analytical testing on raw materials, in-process samples, finished products, and stability time points. The ideal candidate will possess deep expertise in instrumental analysis—specifically HPLC/UHPLC, GC, and Dissolution—and will act as a Subject Matter Expert (SME) in troubleshooting, method transfer, and data integrity compliance during FDA and PIC/S regulatory inspections.

KEY RESPONSIBILITIES 1. Routine & Advanced Analytical Testing:
Execute analytical testing on raw materials, in-process blends, finished dosage forms (solid dose, aqueous solutions), and stability samples in compliance with compendial methods (USP/EP/JP) and in-house specifications. Operate, calibrate, and maintain core analytical instrumentation, including:
High-Performance/Ultra-High-Performance Liquid Chromatography (HPLC/UHPLC) with UV, RI, and ELSD detectors. Gas Chromatography (GC) for residual solvent analysis. Automated Dissolution Testers (Apparatus 1 &
2). Spectroscopic equipment (FT-IR, UV-Vis). Wet chemistry techniques (Karl Fischer titration, potentiometric titrations, pH). Prepare complex mobile phases, standards, and sample solutions requiring precise quantitative techniques.
2. Data Review & Regulatory Compliance:
Ensure absolute adherence to ALCOA+ data integrity principles; document all work contemporaneously in Electronic Lab Notebooks (ELNs) and Laboratory Information Management Systems (LIMS). Perform peer review and second-person verification of analytical data, instrument printouts, and Empower/Chromatography Data System (CDS) audit trails to ensure 21 CFR Part 11 compliance. Lead Phase I Laboratory Investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), and aberrant results, utilizing root cause analysis (RCA) tools to identify systemic issues.

Draft, revise, and approve Standard Operating Procedures (SOPs), test methods, and technical reports.
3. Equipment Qualification & Method Lifecycle:
Support the Commissioning, Qualification, and Validation (IQ/OQ/PQ) of new laboratory instrumentation and software systems. Execute analytical method transfer and co-validation protocols (e.g., Linearity, Accuracy, Precision, Robustness) in accordance with ICH Q2(R2) guidelines. Diagnose and troubleshoot instrument performance issues; coordinate with vendors for preventative maintenance (PM) and out-of-tolerance (OOT) calibrations.
4. Laboratory Operations & Mentorship:
Manage the qualification, bridging, and inventory of critical Tier 1 and Tier 2 consumable reagents, HPLC columns, and USP reference standards. Ensure safe handling and segregation of chemical waste (flammable solvents, acids/bases, HPAPIs) in compliance with Environmental Health & Safety (EHS) guidelines. EDUCATION / TRAINING Bachelor’s degree (B.S. or B.A.) in Chemistry, Analytical Chemistry, Biochemistry, or a closely related scientific discipline.

Minimum of 8+ years of hands-on analytical laboratory experience within a cGMP pharmaceutical, biotech, or contract testing organization (CRO/CDMO). TECHNICAL SKILLS & KNOWLEDGE Demonstrated mastery of HPLC/UHPLC troubleshooting, method execution, and quantitative analysis. Extensive experience with Chromatography Data Systems (e.g., Waters Empower 3 or Thermo Chromeleon). Strong understanding of FDA, PIC/S, and ICH regulatory guidelines pertaining to quality control and data integrity.

Experience performing analytical investigations (OOS/OOT). Familiarity with cloud-based QMS (e.g., ACE, Master Control, Veeva) and LIMS platforms is highly preferred. Work Environment & Physical Demands Ability to work in a laboratory environment, requiring the use of standard Personal Protective Equipment (PPE) such as lab coats, safety glasses, and gloves. Ability to safely handle hazardous chemicals, active pharmaceutical ingredients (APIs), and organic solvents.

Ability to lift up to 25 lbs. and perform tasks requiring manual dexterity and prolonged periods of standing or sitting at a bench. CORE COMPETENCIES Strong leadership, coaching, and communication skills. High decision‑making aptitude and risk‑based thinking. Proficient in data trending, problem‑solving, and scientific writing. Exceptional organization, prioritization, and follow‑through. Ability to operate independently with minimal supervision. Strong competency with Microsoft Office and electronic quality systems.