Analytical Chemist

Position Summary

This role performs day-to-day analytical testing in support of R&D, Manufacturing, Quality, and Biocompatibility groups within Analytical Chemistry Shared Services. The analyst executes validated and transferred test methods—including targeted analyte content, release/elution profiling, and related chemical characterization assays—following FDA, ICH, ISO 17025, and internal QMS requirements.

The role is responsible for accurate sample preparation, instrument operation, data analysis, documentation, and adherence to Good Documentation Practices. Test methods routinely include HPLC for analyte quantitation and release profiles, HS-GC for residual solvents, FTIR for comparative characterization, and GPC for polymer molecular weight determination.

The analyst ensures high-quality analytical output, instrument readiness, and audit-ready data packages, supporting uninterrupted laboratory operations and successful TMV execution at the Lab Supervisor's direction.

Principal Responsibilities

•    Perform targeted analyte content and release/elution testing using validated HPLC methods and other routine analytical techniques (GC, FTIR, GPC).
•    Execute accurate sample preparation across biological matrices, extracts, polymer materials, and catheter components.
•    Operate analytical instruments, complete system suitability checks, and perform basic troubleshooting and routine maintenance.
•    Review data for accuracy, proper calibration, integration quality, and compliance with method and QMS requirements.
•    Document all testing activities in accordance with GDP, ensuring complete and audit-ready records.
•    Receive, log, label, and sequence samples correctly within analytical batches (blanks, standards, samples, checks).
•    Escalate deviations, instrument issues, or atypical results promptly to supervisory staff.
•    Support TMV and method transfer activities as assigned.
•    Maintain laboratory cleanliness, chemical inventory, safe practices, and adherence to PPE and QMS procedures.
•    Participate in required training, cross-training, and competency assessments to support sustained laboratory operations.

Education / Experience Requirements

•    Bachelor’s Degree in Chemistry, Biochemistry, or a related scientific discipline.
•    Minimum 2 years experience performing analytical chemistry testing in a regulated laboratory (medical device, pharmaceutical, or similar).
•    Hands-on experience with HPLC and/or GC-MS instrumentation.
•    Experience with targeted analyte testing in analytical and biological matrices strongly preferred.

Specialized Skills / Other Requirements

•    Proficiency in analytical sample preparation and execution of chromatographic/spectroscopic methods.
•    Ability to interpret analytical results, apply system suitability requirements, and recognize assay failures.
•    Strong attention to detail and adherence to documented procedures.
•    Competence with laboratory software (e.g., ChemStation, LIMS, Excel).
•    Effective communication and ability to work within a multi-disciplinary team.
•    Ability to prioritize work in a fast-paced lab environment with minimal supervision. Interpersonal skills; working in a team and as an individual contributor
•    Foster a positive culture of growth, collaboration, and achievement across the organization

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 0-5 %

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☒ Laboratory