Extractables & Leachables Chemist

Millipore Corporation; Burlington (MA); On-site; USD 40,000 - 61,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perks

Job summary

MilliporeSigma in Burlington, MA, seeks a meticulous Chemist for the Extractables and Leachables team within the North American Validation Services group. You will autonomously perform feasibility and standard E&L testing using HPLC, GC-MS, and LC-MS, ensuring compliant data delivery to clients.

The role requires a chemistry degree and 1+ years of analytical experience in pharma/medical devices, with hands-on GC/LC-MS capabilities.

Qualifications

• Bachelor's degree in Chemistry or related science.
• 1+ years in analytical chemistry within pharma/medical device.
• Experience with GC, LC-MS, HPLC, UHPLC, and MS preferred.

Responsibilities

• Perform extractables and leachables testing following SOPs.
• Prepare samples for GC/LC analysis and run GC/LC instruments.
• Generate valid test data per ALCOA+ and Good Documentation Practices.
• Maintain safety rules and handle solvents and samples appropriately.
• Support lab with internal audits and guideline compliance.
• Seek improved testing efficiency and process optimization.

Skills

Headspace GC

GC-MS

LC-MS

HPLC

UHPLC

Mass spectrometry

Analytical chemistry

Safety compliance

Documentation

Education

Bachelor's degree in Chemistry or related science

Tools

Gagetrack

LIMS

ELN

Mango

Trackwise

SFDC

SharePoint

LabVantage

Oracle

Mass Hunter

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma.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.

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
• Demonstrated troubleshooting competencies and the ability to manage change and implement improvement solutions
• Strong background in Chemistry, excellent organizational and interpersonal skills, and a commitment to safety and compliance

Pay Range for this position: $29.00 - $44.00/hourThe offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

RSREMDWhat we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!