Scientist

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: Scientist / Senior Scientist – Chemical Characterization, Extractables & Leachables, & Mass Spectrometry

Department: Analytical Chemistry

Location: Onsite at Canyon Labs in Rush, NY or Remote

Annual Salary Range: $65,000.00 - $110,000.00

Job Summary:

We are seeking a highly motivated and detail-oriented Scientist to join our analytical testing laboratory. The Scientist/Senior Scientist – Chemical Characterization, Extractables & Leachables, & Mass Spectrometry is a senior technical contributor responsible for the execution of complex chemical characterization and extractables and leachables (E&L) studies supporting medical device and pharmaceutical clients. This role combines hands-on laboratory execution with advanced scientific interpretation, serving as a subject matter expert in LC-MS and GC-MS analysis, structural elucidation of unknown compounds, and mass spectral interpretation.

The successful candidate will independently execute technically challenging studies, develop and validate analytical methods, mentor junior scientists, and provide scientific guidance on study design while remaining actively engaged in laboratory operations. This position offers the opportunity to contribute to the continued expansion of Canyon Labs' chemical characterization and mass spectrometry capabilities through continuous improvement, technical innovation, and scientific excellence.

*Title and compensation commensurate with education, experience, and demonstrated technical expertise.

Key Responsibilities:

Chemical Characterization & Extractables/Leachables

· Independently execute and technically lead chemical characterization and extractables & leachables studies in accordance with approved protocols and client specifications.

· Design extraction strategies with scientific justifications consistent with ISO 10993-18, USP <1663> , USP <1664> , and applicable regulatory guidance.

· Serve as the technical lead for complex projects requiring advanced scientific interpretation and problem solving.

· Provide technical consultation to project managers and clients regarding study design, analytical strategies, and interpretation of results.

Advanced Mass Spectrometry & Structural Elucidation

· Perform advanced interpretation of LC-MS and GC-MS data for identification of unknown compounds generated during chemical characterization and extractables & leachables studies.

· Utilize mass spectral fragmentation patterns, isotopic distributions, accurate mass measurements (when available), adduct chemistry, and chromatographic behavior to support structural elucidation.

· Perform non-targeted analysis (NTA) and unknown compound identification using commercially available spectral libraries and scientific interpretation.

· Evaluate proposed compound identifications and assign scientifically defensible confidence levels.

· Recommend orthogonal analytical techniques when additional confirmation is required.

· Document scientific rationale supporting compound identification within technical reports and client deliverables.

· Mentor laboratory personnel in advanced mass spectral interpretation and data evaluation.

Data Review & Scientific Reporting

· Independently review analytical data for accuracy, completeness, and scientific integrity.

· Interpret complex analytical datasets and defend conclusions using sound scientific principles.

· Prepare or review GMP-compliant protocols, reports, SOPs, technical summaries, and scientific justifications.

· Support client discussions involving technically challenging analytical findings.

Technical Leadership & Continuous Improvement

· Mentor scientists in advanced analytical chemistry techniques and mass spectral interpretation.

· Support continuous improvement of laboratory workflows, analytical methodologies, and data review practices.

· Evaluate emerging analytical technologies and recommend improvements to enhance laboratory capabilities.

· Contribute technical expertise toward expanding Canyon Labs' chemical characterization and extractables & leachables service offerings.

Scientist Qualifications:

Required:

Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related discipline with 2+ years of relevant industry experience. OR M.S. with 5+ years of directly relevant experience. OR B.S. with 8+ years of directly relevant experience.

Demonstrated experience performing chemical characterization and extractables & leachables studies in a regulated laboratory environment.

Strong hands-on experience with LC-MS and GC-MS instrumentation.

Demonstrated expertise interpreting complex mass spectra and identifying unknown compounds through mass spectral interpretation.

Experience developing, validating, verifying, and transferring analytical methods.

Strong understanding of chromatographic separations, mass spectrometry, and analytical chemistry principles.

Preferred:

· Experience performing non-targeted analysis (NTA) and structural elucidation of unknown compounds.

· Experience with high-resolution mass spectrometry (QTOF, Orbitrap, TOF, or equivalent).

· Experience with spectral interpretation software and databases (NIST, Wiley, mzCloud, MassBank, METLIN, or similar).

· Experience supporting ISO 10993-18 chemical characterization studies.

· Experience with USP <1663> , USP <1664> , PQRI recommendations, and FDA expectations for extractables & leachables.

· Experience working within a GMP contract testing laboratory.

· Experience mentoring technical staff and serving as a scientific resource on complex analytical projects.

· Familiarity with Agilent MassHunter, Thermo Xcalibur, Chromeleon, or equivalent data systems.

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.