Extractables & Leachables Chemist

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
At MilliporeSigma 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.
Responsibilities:
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
Who You Are:
Minimum Qualifications:
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
Preferred Qualifications:
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 Validation Services operational systems such as, but not limited to: Mango, Trackwise, SFDC, Sharepoint, LabVantage and Oracle
Excellent communication skills, both verbal and written
Excellent knowledge of good laboratory practices, cGMP, regulatory guidance, and recommendations as well as demonstrable operational management abilities