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.

Position Title: Senior 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

Job Overview:

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 MassHunter 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.

Primary Responsibilities:

Extractables & Leachable Testing (GMP Execution)

• 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.

LC–MS & GC–MS Quantitative Analysis

• 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 MassHunter 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.

Method Validation, Verification & Transfer

• Author and execute method validation and verification protocols in a GMP environment, including:
• Specificity/selectivity
• Linearity and range
• Accuracy and precision
• LOD/LOQ determination
• 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.

Data Review, Interpretation & Reporting

• 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 ID experience is a plus.

GMP Compliance & Quality Support

• 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 contemporaneous laboratory documentation consistent with ALCOA+ principles.

Client Interaction & Mentorship

• 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
• Efficient, compliant execution of E&L workflows
• Contribute to laboratory efficiency, consistency, and technical excellence in a contract testing environment.

Education and Experience:

• 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 testing in a pharmaceutical or contract lab setting.
• Proficiency with Agilent MassHunter for acquisition, processing, and reporting.
• Solid understanding of GMP laboratory operations, documentation, and data integrity requirements.
• Proven ability to independently execute studies, review data, and author defensible technical reports.

Preferred Qualifications:

• Prior experience in a GMP contract testing laboratory environment.
• Experience supporting multiple product types (parenteral, inhalation/nasal, ophthalmic, combination products).
• Familiarity with USP and , PQRI best practices, and common global regulatory expectations for E&L.
• Prior HRMS (QTOF/Orbitrap) experience for extractables screening or unknown identification.
• Experience with headspace GC–MS, SPME, or thermal desorption techniques.

Canyon Labs offers several benefits as part of your total compensation, including but not limited to:

• Paid Time Off, Sick Time, and Paid Holidays
• Medical, Dental and Vision Insurance
• Long term disability insurance, life insurance
• 401(k) with company match up to 4%

At Canyon Labs, we are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.