Sr Analytical Scientist

Job Title

Sr Analytical Scientist

• PhD in Analytical Chemistry or a related scientific field.
• At least 5 years of industry experience in analytical chemistry or a closely related discipline.
• Strong expertise in LC/MS and high‑resolution mass spectrometry (HRMS), including LC‑MS/MS and LC‑HRMS.
• Deep understanding of mass spectrometry principles, fragmentation mechanisms, and structure elucidation.
• Solid organic chemistry experience with practical experience in structure confirmation of unknown compounds.
• Experience working in GLP, GMP, and ISO‑regulated laboratory environments.
• Proficiency with mass spectrometry software platforms such as Sciex OS and Thermo/Chromeleon (or similar systems).
• Demonstrated ability to operate, maintain, and troubleshoot LC/MS and HRMS instrumentation.
• Strong problem‑solving skills with a track record of resolving complex analytical issues.
• Excellent written and verbal communication skills for preparing reports and collaborating with cross‑functional teams.
• Proven mentorship and training abilities to support development of junior scientists.

• Experience with GC/MS techniques is highly desirable.
• Experience in analytical chemistry with emphasis on pharmaceutical, biotech, or medical device applications.
• Familiarity with extractables and leachables (E&L) studies and related regulatory expectations.
• Experience preparing and reviewing documentation aligned with standards such as ISO‑18 and USP.
• Ability to stay current with emerging analytical technologies and implement improvements in laboratory workflows.
• Strong collaboration skills and comfort working closely with quality assurance and cross‑functional scientific teams.
• Commitment to supporting a mission‑driven organization focused on improving public health through science.

The Sr Analytical Scientist leads unknown compound identification using advanced mass spectrometry techniques to support pharmaceutical, medical device, and extractables and leachables (E&L) studies. This role requires deep expertise in LC/MS, strong knowledge of regulatory expectations, and the ability to provide technical leadership in solving complex analytical challenges within a cGMP/GLP testing environment focused on improving public health.

• Lead unknown peak identification activities using LC/MS, LC‑MS/MS, and high‑resolution mass spectrometry (LC‑HRMS) to support pharmaceutical, medical device, and E&L studies.
• Operate, maintain, and troubleshoot LC/MS and high‑resolution MS instruments, ensuring reliable performance and high‑quality data output.
• Interpret complex mass spectrometry data, including fragmentation patterns and structural information, to identify and confirm unknown compounds.
• Investigate and resolve analytical challenges related to methods, instrumentation, and complex sample matrices, proposing and implementing effective solutions.
• Prepare and review detailed technical reports, study protocols, and regulatory documentation in alignment with relevant guidelines such as ISO‑18 and USP.
• Collaborate closely with cross‑functional teams, including quality assurance, to communicate analytical results and provide expert technical guidance.
• Mentor and train junior scientists in mass spectrometry techniques, data interpretation, and unknown identification strategies.
• Stay current with emerging analytical technologies, methodologies, and regulatory trends, and drive continuous improvement in laboratory practices and workflows.
• Support cGMP/GLP testing activities in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology by providing advanced analytical expertise.
• Contribute to a mission‑driven culture focused on improving public health through high‑quality scientific work.

This is an onsite role working in a cGMP/GLP laboratory that supports toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology testing for pharmaceutical, biotech, and medical device clients. The position follows standard daytime hours, Monday through Friday, 8:30 a.m. to 5:00 p.m. You will work with advanced LC/MS, LC‑MS/MS, high‑resolution MS…