Extractables & Leachables Chemist

Analytical chemist, Liquid chromatography-mass spectrometry, Gas chromatography-mass spectrometry, Quality Control (QC), Liquid chromatography, Gas chromatography

Our passion for science and technology is what drives our more than 64,000 employees across 66 countries to find solutions to some of today’s toughest challenges and create more sustainable ways to live.

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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

At Millipore Sigma in Burlington, MA, we are seeking a detailed and results-oriented Chemist for our Extractables and Leachables (E&L) team within the North American Validation Services group. The successful candidate will be a part of a diverse team of scientists, specialists, and assistants, ensuring the delivery of compliant testing services that align with business objectives. In this role you will autonomously perform feasibility, standard and non-standard Extractables and Leachables testing following Protocols and SOPs on HPLC, GCMS and LCMS equipment.

• Perform all laboratory activities strictly in accordance with approved SOPs, analytical methods, study protocols, laboratory instructions, and applicable safety requirements
• Prepare samples for GC- and LC-based analysis
  , including but not limited to liquid-liquid-extraction, dilution, filtration, concentration, derivatization, and transfer into analytical vials, as specified in the approved method or protocol
• Operate GC and LC instrumentation in accordance with approved SOPs, analytical methods, study protocols, instrument procedures, and training requirements
• Conduct extractables and leachables extraction using the defined solvents, extraction conditions, temperatures, times, oven/shaker, and sample-to-solvent ratios
• Prepare test solutions, calibration standards, system suitability solutions, blanks, spiked samples, and quality control samples according to approved procedures
• Thoroughly read protocols and plan proactively for testing including equipment and chemical needs
• Generate valid test data (ensuring accuracy and completeness) for customers in a timely manner according to Good Documentation Practices and ALCOA+ principles
• Handle solvents and customer product samples in accordance with all safety rules (PPE, MSDS and EHS recommendations to be considered before handling the products)
• Assist with self-inspections and audits and work as “Junior SME” to support lab on technical guidelines
• Maintain a Growth Mindset, seeking opportunities to improve test efficiency and processes, approaching change with a spirit of curiosity

• Bachelor’s Degree in Chemistry, Biochemistry or other Science discipline
• 1+ years of experience in analytical chemistry within the pharmaceutical or medical device industry
• 1+ years of experience with headspace GC, GC-MS, LC-MS, HPLC, UHPLC, or high-resolution mass spectrometry

• Experience in extractables and leachables testing or related trace-level analytical testing
• Experience with laboratory electronic systems, including but not limited to:
  Gagetrack, LIMS, ELN, BMS, ECM, Mass Hunter etc.
• Strong working knowledge of…