Senior E&L Scientist

Job Title:

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

LC/MS, LC

‑MS/MS, and high‑resolution mass spectrometry (LC‑HRMS) analyses to detect, characterize, and identify extractables and leachables. Operate, maintain, and troubleshoot LC/MS and high‑resolution MS instrumentation to ensure reliable and accurate performance. Interpret complex LC/MS and HRMS data, including fragmentation patterns and spectral features, to support structure elucidation of unknown compounds. Resolve analytical challenges related to methods, instrumentation, and complex sample matrices, proposing and implementing effective solutions. Design, prepare, and review study protocols, technical reports, and regulatory documentation in alignment with

ISO 10993

‑18 and USP / guidelines. Ensure all analytical work complies with GLP, GMP, and applicable ISO quality and regulatory requirements. Collaborate with cross‑functional teams, including quality assurance and project stakeholders, to communicate findings and provide expert technical guidance. Mentor, train, and support junior chemists in LC/MS techniques, data interpretation, and unknown identification strategies. Stay current with emerging technologies, methodologies, and regulatory expectations in E&L analysis and mass spectrometry. Drive continuous improvement in E&L analytical workflows, instrumentation utilization, and data quality. Contribute to a culture of scientific excellence, quality, and integrity in all aspects of laboratory work. 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) studies 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. Experience working in GLP, GMP, and ISO‑regulated laboratory environments. Proficiency in operating, maintaining, and troubleshooting LC/MS and HRMS instrumentation. Excellent analytical and problem‑solving skills, especially in resolving complex analytical and instrumentation challenges. Strong written and verbal communication skills for preparing and reviewing technical reports, study protocols, and regulatory documentation. Demonstrated ability to mentor, train, and support junior scientists and chemists. Additional Skills & Qualifications Experience with GC/MS techniques is a plus. Familiarity with Thermo Orbitrap mass spectrometers and Chromeleon software is preferred. Experience preparing documentation compliant with

ISO 10993

‑18 and USP / guidelines. background in analytical chemistry applied to pharmaceutical, biotech, or medical device industries. Ability to collaborate effectively with cross‑functional teams, including quality assurance and project teams. Commitment to continuous learning and staying current with emerging technologies in E&L analysis and mass spectrometry. Work Environment This is a fully onsite role, based in a laboratory environment operating under cGMP, GLP, and ISO quality systems. The position follows normal business hours, five days per week, with some weekend work potentially required to meet project timelines or support critical studies. The work involves routine use of advanced analytical instrumentation, including LC/MS and high‑resolution mass spectrometers, within a professional, science‑driven contract research setting that supports clients in the pharmaceutical, biotechnology, and medical device sectors. The culture emphasizes scientific rigor, regulatory compliance, collaboration, and a shared mission to improve public health through high‑quality analytical testing. 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 Apr 30, 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.