Senior E&L Chemist, Analytical Services at Pacific BioLabs · Hercules

Apply Job Type Full-time Description Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently hiring to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science! Pacific BioLabs has an immediate opening for a full time Senior Scientist I/II with expertise in Extractables and Leachables in the Analytical Services Department. The highly experienced and technically adept extractables and leachables chemist will lead efforts in identifying unknown peaks in complex samples using advanced Liquid Chromatography-Mass Spectrometry (LC/MS) techniques. This role requires a strong understanding of LC/MS instrumentation, method development, and organic chemistry. A proven track record in elucidating the structure of unknown compounds is also required. The Scientist will support various extractables and leachables (E&L) projects for both medical device and pharmaceutical products, troubleshoot analytical challenges, and provide expert insights into complex chemical compositions. PRIMARY RESPONSIBILITIES FOR THE EXTRACTABLES AND LEACHABLES SENIOR SCIENTIST INCLUDE Lead unknown peak identification: Utilize LC/MS, LC-MS/MS, and high-resolution mass spectrometry (LC-HRMS) to identify unknown compounds in pharmaceutical and medical device E&L samples, and other products. Data acquisition and interpretation: Operate and maintain LC/MS and LC-HRMS instruments, acquire complex mass spectrometry data, and perform advanced data analysis for the elucidation of unknown structures. Experience with Thermo Orbitrap software (Chromeleon) strongly desired. Troubleshooting and problem-solving: Investigate and resolve analytical issues related to unknown peaks, including method problems, instrument malfunctions, and complex sample matrix interferences. Collaboration and communication: Work effectively with cross-functional teams, including other instrumentation groups, and quality assurance, to communicate findings, discuss results, and provide technical support related to unknown identification. Documentation and reporting: Prepare detailed technical reports, study protocols, and regulatory documentation, summarizing analytical methods, results, and conclusions in compliance with ISO 10993-18 and USP 1663 and USP 1664 guidance documents. Understanding of GLP, GMP, and ISO 17025 regulation required. Mentorship and training: Provide technical guidance, training, and mentorship to junior chemists on LC/MS techniques, unknown identification strategies, and data interpretation. Stay current with advancements: Continuously research and implement new methodologies, platforms, and technologies to enhance analytical capabilities and address evolving analytical challenges. Requirements QUALIFICATIONS AND SKILLS FOR THE EXTRACTABLES AND LEACHABLES SENIOR SCIENTIST Ph.D. in Analytical Chemistry, or a related field, with 5+ years of experience in extractable and leachables unknown peak identification in a relevant industry (e.g., pharmaceutical, medical device, or CRO). Demonstrated expertise in operating and troubleshooting LC/MS instruments, particularly high-resolution mass spectrometers (LC-HRMS). Additional experience with GC/MS is a plus. Strong organic chemistry background with the ability to distinguish between structures that are possible vs theoretical. Strong understanding of mass spectrometry principles, fragmentation patterns, and spectral interpretation. Experience with various LC/MS techniques, such as ESI, APCI, and different MS/MS modes. Excellent problem-solving, critical thinking, and analytical skills. Strong communication and interpersonal skills, with the ability to collaborate effectively with colleagues and external partners. Experience mentoring and training junior team members is highly desirable. The base pay offered for this position is $110,000 to $140,000 and will take into account internal equity and may also vary depending on the candidate’s job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits. PBL is an equal opportunity employer committed to diversity and inclusion. PBL considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans’ status, or any other legally protected factors.