Extractables & Leachables Chemist

The businesses of Merck KGaA, Darmstadt, Germany•Burlington, MA

2h•$29 - $44•Onsite

About The Position

MilliporeSigma is seeking a detailed and results-oriented Chemist for its Extractables and Leachables (E&L) team within the North American Validation Services group in Burlington, Massachusetts. The role supports a diverse team of scientists, specialists, and assistants in delivering compliant testing services aligned with business objectives. The Chemist autonomously performs feasibility, standard, and non-standard E&L testing under approved protocols and SOPs using HPLC, GC-MS, and LC-MS equipment. The position does not offer work authorization sponsorship; external applicants must be eligible to work in the United States.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, or another science discipline.
At least 1 year of analytical chemistry experience in the pharmaceutical or medical device industry.
At least 1 year of experience with headspace GC, GC-MS, LC-MS, HPLC, UHPLC, or high-resolution mass spectrometry.

Nice To Haves

Experience in extractables and leachables testing or related trace-level analytical testing.
Experience with laboratory electronic systems such as Gagetrack, LIMS, ELN, BMS, ECM, or Mass Hunter.
Working knowledge of Validation Services operational systems such as Mango, Trackwise, SFDC, SharePoint, LabVantage, and Oracle.
Excellent verbal and written communication skills.
Knowledge of good laboratory practices, cGMP, regulatory guidance, and recommendations, along with operational management abilities.
Demonstrated troubleshooting competencies and ability to manage change and implement improvement solutions.
Strong chemistry background, excellent organizational and interpersonal skills, and commitment to safety and compliance.

Responsibilities

Perform laboratory activities in accordance with approved SOPs, analytical methods, study protocols, laboratory instructions, and applicable safety requirements.
Prepare samples for GC- and LC-based analysis, including extraction, dilution, filtration, concentration, derivatization, and transfer into analytical vials as specified by approved methods or protocols.
Operate GC and LC instrumentation in accordance with approved procedures and training requirements.
Conduct extractables and leachables extractions using defined solvents, extraction conditions, temperatures, times, equipment, and sample-to-solvent ratios.
Prepare test solutions, calibration standards, system suitability solutions, blanks, spiked samples, and quality control samples according to approved procedures.
Review protocols and plan testing proactively, including equipment and chemical needs.
Generate accurate and complete test data for customers in a timely manner, following Good Documentation Practices and ALCOA+ principles.
Handle solvents and customer product samples according to safety rules, considering PPE, MSDS, and EHS recommendations.
Assist with self-inspections and audits and support the laboratory as a Junior SME on technical guidelines.
Seek opportunities to improve testing efficiency and processes, approaching change with curiosity.