Sr. Analytical Chemist

Position Summary

This role functions as a senior-level analytical contributor within the Analytical Chemistry Shared Services group. In addition to executing advanced analytical testing, the position is expected to provide technical guidance, support method lifecycle activities, and mentor junior staff.

Under direction of the laboratory supervisor the individual will lead and support complex analytical activities across R&D, Manufacturing, Quality, and Biocompatibility programs, including method validation (TMV), method transfer, and non-routine investigations. Analytical scope includes HPLC-based analyte quantitation and release profiling, GC/MS for extractables and residual analysis, FTIR characterization, and polymer analysis techniques.

The role emphasizes data quality, method robustness, and laboratory capability build-out, contributing to a high-performing, scalable analytical function aligned with FDA, ICH, ISO 17025, and internal QMS requirements.

Principal Responsibilities

•    Serve as a technical lead analyst for HPLC and GC/MS-based methods, including analyte quantitation, release/elution studies, and chemical characterization.
•    Lead and support method validation (TMV), verification, and transfer activities, including protocol development, execution, and data review.
•    Perform and oversee complex sample preparation across biological matrices, polymer systems, extracts, and finished device components.
•    Provide technical troubleshooting and root cause investigation for analytical issues, atypical results, and instrument performance.
•    Mentor junior analysts by providing hands-on training, technical guidance, and review of laboratory practices and data packages.
•    Collaborate cross-functionally with R&D, Quality, and Manufacturing to define analytical strategies and support product development and investigations.
•    Ensure all work is documented in accordance with GDP and QMS requirements, maintaining audit-ready data and reports.
•    Support laboratory readiness by contributing to instrument qualification (IQ/OQ), maintenance strategies, and continuous improvement initiatives.
•    Act as a key contributor to lab ramp-up activities, including capability expansion (e.g., GC/MS, UPLC/MS) and knowledge transfer efforts aligned with organizational growth initiatives.

Education / Experience Requirements

•    Bachelor’s Degree in Chemistry, Biochemistry, or a related scientific discipline.
•    4+ years’ experience performing analytical chemistry testing in a regulated laboratory (medical device, pharmaceutical, or similar).
•    Demonstrated experience with HPLC and GC/MS, including method development, troubleshooting, and validation activities.
•    Experience supporting method validation (ICH/ISO-aligned) and analytical investigations strongly preferred.
•    Prior experience mentoring or training junior staff 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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