Scientist

About the role

Canyon Labs is looking for a dedicated Scientist to join our analytical testing team. This position focuses on chemical characterization and extractables and leachables studies, primarily serving clients in the medical device and pharmaceutical sectors. The ideal candidate will combine laboratory expertise with advanced scientific analysis, particularly in mass spectrometry.

Key facts

What you'll do

• Conduct and lead complex chemical characterization and extractables and leachables studies, adhering to established protocols and client requirements.
• Develop extraction strategies that align with ISO 10993-18, USP <1663>, USP <1664>, and relevant regulatory guidelines.
• Act as the technical authority on intricate projects, providing insights and solutions to scientific challenges.
• Offer technical advice to project managers and clients regarding study design and analytical approaches.
• Analyze LC-MS and GC-MS data to identify unknown compounds and support structural elucidation.
• Document findings and scientific rationale in technical reports and client deliverables.
• Review analytical data for accuracy and completeness, ensuring scientific integrity in all conclusions.
• Mentor junior scientists in advanced analytical techniques and mass spectral interpretation.
• Contribute to the enhancement of laboratory processes, methodologies, and data review practices.

Requirements

• Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field with a minimum of 2 years of relevant industry experience; OR M.S. with at least 5 years of relevant experience; OR B.S. with 8 or more years of directly relevant experience.
• Proven experience in chemical characterization and extractables and leachables studies within a regulated laboratory setting.
• Strong hands-on experience with LC-MS and GC-MS instrumentation.
• Expertise in interpreting complex mass spectra and identifying unknown compounds.
• Experience in developing, validating, and transferring analytical methods.
• Solid understanding of chromatographic techniques and analytical chemistry principles.

Nice to have

• Experience with non-targeted analysis and structural elucidation of unknown compounds.
• Familiarity with high-resolution mass spectrometry techniques (QTOF, Orbitrap, TOF, or similar).
• Knowledge of spectral interpretation software and databases (NIST, Wiley, mzCloud, MassBank, METLIN, etc.).
• Background in supporting ISO 10993-18 chemical characterization studies.
• Experience with USP <1663>, USP <1664>, PQRI recommendations, and FDA expectations for extractables and leachables.
• Previous experience in a GMP contract testing laboratory.
• Experience mentoring technical staff and acting as a scientific resource on complex analytical projects.
• Familiarity with data systems like Agilent MassHunter, Thermo Xcalibur, or Chromeleon.

Skills & tools

• LC-MS and GC-MS instrumentation
• Mass spectral interpretation
• Analytical method development and validation
• Chromatographic techniques
• Technical report writing

Practical notes

Annual Salary Range: $65,000 - $110,000, commensurate with education and experience. Canyon Labs offers a comprehensive benefits package, including paid time off, medical, dental, and vision insurance, long-term disability and life insurance, and a 401(k) plan with company matching up to 4%.

Canyon Labs is dedicated to fostering a diverse and inclusive work environment. We provide equal employment opportunities to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, veteran status, or any other protected characteristic under applicable laws.