Canyon Labs: Sr. Scientist, Extractables & Leachable; E&L

Canyon Labs:
Sr. Scientist, Extractables & Leachable (E&L)

Location:

Onsite at Canyon Labs in Bluffdale, Utah

Schedule:

Monday – Friday 8:00AM – 5:00PM

Annual Salary Range: $90,000 - $105,000

The Senior Scientist – Extractables & Leachable (E&L) is a senior-level technical contributor in a GMP-regulated contract testing laboratory, responsible for the execution, oversight, and scientific defense of extractables and leachable studies for a wide range of pharmaceutical and combination products. The role emphasizes quantitative LC–MS and GC–MS analysis using single quadrupole and triple quadrupole platforms, with Agilent Mass Hunter as the exclusive data system.

This position serves as a key technical authority for method development, method validation/verification, complex data interpretation, and GMP documentation, while supporting client-facing activities, audits, and regulatory submissions.

• Independently execute and/or technically lead extractables and leachable studies in accordance with approved protocols, GMP requirements, and client specifications.
• Support E&L testing across all product categories, including Parenterals (vials, stoppers, prefilled syringes, cartridges), Inhalation and nasal products, Ophthalmic products, Oral and topical drug products, and Combination products and delivery devices (tubing, filters, IV sets, bags, pumps).
• Apply risk-based E&L principles to support appropriate solvent selection, extraction conditions, and analytical coverage while operating within contract lab scopes.
• Serve as a technical escalation point for atypical results, deviations, OOS/OOT investigations, and client questions.

• Develop, optimize, qualify, and validate quantitative methods using LC–MS (single quad and triple quad) and GC–MS.
• Perform targeted quantification using external/internal standard calibration, appropriate integration strategies, and scientifically justified reporting limits.
• Operate, maintain, and troubleshoot Agilent LC–MS and GC–MS systems using Mass Hunter software for data acquisition, processing, quantitation, reporting, system suitability, tuning, and routine performance verification.
• Support confirmatory analysis and orthogonal techniques (LC‑UV, GC‑FID, ICP‑MS) as required.
• Author and execute method validation and verification protocols in a GMP environment, covering linearity, range, accuracy, precision, robustness, and carryover.
• Ensure analytical methods are fit for purpose and defensible for regulatory review.

• Perform independent data review of chromatograms, integrations, calibration curves, and calculations.
• Interpret and defend analytical results, including low-level detections near reporting thresholds.
• Author or review GMP‑compliant analytical reports, method validation reports, and technical summaries and response documents for clients.
• Support identification and justification of unknowns using library searches and fragmentation interpretation; prior HRMS-based identification experience is a plus.

• Operate in strict compliance with cGMP, data integrity, and laboratory SOPs.
• Support deviations, OOS/OOT investigations, CAPAs, internal, client, and regulatory audits, change controls, and continuous improvement initiatives.
• Maintain accurate and contemporaneous laboratory documentation consistent with ALCOA+ principles.
• Serve as a technical contact for clients on assigned studies, supporting scientific discussions and troubleshooting.
• Mentor junior scientists and analysts in mass spectrometry best practices, GMP documentation, and data review.
• Contribute to laboratory efficiency, consistency, and technical excellence in a contract testing environment.

• PhD in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related discipline with 3+ years relevant industry experience.
• OR MS with 6+ years OR BS with 8+ years experience in a GMP laboratory.
• Strong hands‑on experience with LC–MS and GC–MS quantitative analysis, particularly using single quad and triple quad instrumentation.
• Demonstrated experience performing E&L…