Senior E&L Scientist

Job Title:

Senior Scientist - Extractables and Leachables (E&L), LC/MS Job Description The Senior Scientist leads extractables and leachables (E&L) investigations, specializing in the identification of unknown compounds in complex pharmaceutical and medical device samples using advanced LC/MS techniques. This role requires deep technical expertise in analytical chemistry, strong understanding of regulatory expectations, and the ability to solve complex analytical challenges while supporting high‑quality, compliant studies that advance public health. Responsibilities Lead extractables and leachables (E&L) investigations for pharmaceutical and medical device projects, with a primary focus on unknown compound identification. Perform advanced unknown compound identification using

LC/MS, LC

‑MS/MS, and high‑resolution mass spectrometry (LC‑HRMS). Operate, maintain, and troubleshoot LC/MS and high‑resolution MS instrumentation to ensure reliable and robust performance. Interpret complex LC/MS and HRMS data, including fragmentation patterns and spectral information, to support structure elucidation and compound identification. Resolve analytical challenges related to methods, instrumentation, and complex sample matrices, proposing and implementing effective solutions. Develop, optimize, and refine analytical methods to support E&L studies and unknown identification workflows. Prepare, review, and approve technical reports, study protocols, and regulatory documentation in alignment with

ISO 10993

‑18 and USP / requirements. Ensure all work complies with GLP, GMP, ISO, and relevant regulatory standards and internal quality procedures. Collaborate closely with cross‑functional teams, including quality assurance and project stakeholders, to communicate findings and provide expert technical guidance. Mentor, train, and support junior chemists and scientists in LC/MS techniques, data interpretation, and unknown identification strategies. Stay current with emerging technologies, software, and best practices in mass spectrometry and E&L analysis, and drive continuous improvement initiatives. Contribute scientific expertise to study design, problem solving, and strategic planning for client and internal projects. Essential Skills PhD in Analytical Chemistry or a closely related field. At least 5 years of hands‑on experience in extractables and leachables (E&L) and unknown compound identification. Strong expertise in LC/MS and high‑resolution mass spectrometry (HRMS), including LC‑MS/MS and LC‑HRMS. Solid background in organic chemistry and structure elucidation. Deep understanding of mass spectrometry principles, including ionization, fragmentation, and spectral interpretation. Demonstrated experience working in GLP, GMP, and ISO‑regulated laboratory environments. Proficiency in analytical chemistry techniques relevant to E&L studies. Proven ability to operate, maintain, and troubleshoot LC/MS and HRMS instrumentation. Excellent problem‑solving skills, with the ability to address complex analytical and technical issues. Strong written and verbal communication skills for preparing reports, protocols, and regulatory documentation, and for communicating findings to diverse stakeholders. Demonstrated ability to mentor, train, or guide junior scientific staff. Additional Skills & Qualifications Experience with GC/MS is a strong plus. Experience with Thermo Orbitrap mass spectrometers and Chromeleon software is preferred. Prior work in a contract research organization (CRO) or similar client‑focused environment is beneficial. Familiarity with regulatory expectations for pharmaceutical, biotech, and medical device testing. Strong collaboration skills and the ability to work effectively in cross‑functional teams. Commitment to continuous learning and staying current with emerging technologies in E&L and mass spectrometry. Work Environment This is a fully onsite role, working five days per week during normal business hours, with some weekend work potentially required based on project needs. The position is based in a regulated laboratory environment that supports cGMP and GLP testing across toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. You will work with advanced LC/MS and high‑resolution mass spectrometry systems, including Thermo Orbitrap platforms and Chromeleon software, within an ISO‑compliant setting. The culture emphasizes scientific excellence, regulatory compliance, collaboration, and a shared mission to improve public health through science. Job Type & Location This is a Contract to Hire position based out of Hercules, CA. Pay and Benefits The pay range for this position is $52.88 - $67.30/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Hercules,CA.

Application Deadline This position is anticipated to close on May 11, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.