Sr. Scientist – Extractables & Leachable; E&L

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging.

We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives.

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. Prior HRMS experience is considered a strong plus, but the primary focus is robust, defensible targeted quantification in a high-throughput contract lab environment.

• 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 but not limited to:
  • Parenterals (vials, stoppers, prefilled syringes, cartridges)
  • Inhalation and nasal products
  • Ophthalmic products
  • Oral and topical drug products
  • 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) for semi-volatile and non-volatile extractables/leachables
  • GC–MS for volatile and semi-volatile compounds (including headspace and direct injection)
• 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, and reporting
  • System suitability, tuning, and routine performance verification
  • Support confirmatory analysis and orthogonal techniques (e.g., LC-UV, GC-FID, ICP-MS) as required by protocols or investigations.
• Author and execute method validation and verification protocols in a GMP environment, including:
  • Linearity and range
  • Accuracy and precision
  • Robustness and carryover
• Support method transfers from clients or development groups into routine GMP testing.
• 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
  • Technical summaries and response documents for clients
• Support identification and justification of unknowns using library searches and fragmentation interpretation; prior HRMS-based  is a plus.

• Operate in strict compliance with cGMP, data integrity, and laboratory SOPs.
• Support:
  • Deviations, OOS/OOT investigations, and CAPAs
  • Internal, client, and regulatory audits
  • Change controls and continuous improvement initiatives
  • Maintain accurate and…