Extractables & Leachables Chemist

Merck•Burlington, MA

24d•Onsite

About The Position

MilliporeSigma is seeking a detailed, results-oriented Chemist to join its Extractables and Leachables (E&L) team within the North American Validation Services group in Burlington, Massachusetts. The role contributes to compliant testing services aligned with business objectives and involves autonomously conducting feasibility, standard, and non-standard E&L testing under approved protocols and SOPs using HPLC, GC-MS, and LC-MS equipment. The Chemist prepares samples and test solutions, performs extractions, operates analytical instruments, and generates accurate, complete customer data in a timely manner. The role also supports inspections and audits, provides junior subject matter expertise on technical guidelines, and seeks opportunities to improve testing efficiency and processes. Applicants must be eligible to work in the United States; the role does not offer work authorization sponsorship.

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, or Oracle.
Excellent verbal and written communication skills.
Knowledge of good laboratory practices, cGMP, regulatory guidance, and recommendations, as well as operational management abilities.
Troubleshooting competencies and ability to manage change and implement improvement solutions.
Strong chemistry background, 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, protocols, and training requirements.
Conduct extractables and leachables extractions using defined solvents, 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.
Read protocols thoroughly 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 in accordance with safety rules, PPE requirements, 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 test efficiency and processes, approaching change with curiosity.