Senior Analytical Chemist

1d1 day ago

Teleflex

Morrisville, US · Full-time · $115,000 – $155,000

About this role

This role functions as a senior-level analytical contributor within the Analytical Chemistry Shared Services group at Teleflex. Execute advanced analytical testing while providing technical guidance, supporting method lifecycle activities, and mentoring junior staff. Teleflex offers medical technology solutions in anesthesia, emergency medicine, and urology.

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.

Work within Global Operations, a customer-centric organization focused on improving quality, service, and value. Collaborate cross-functionally with R&D, Quality, and Manufacturing teams to define analytical strategies and support product development. Ensure data quality, method robustness, and compliance with FDA, ICH, ISO 17025, and internal QMS requirements.

Contribute to laboratory capability build-out and ramp-up activities, including instrument qualification (IQ/OQ), maintenance strategies, and expansion like GC/MS and UPLC/MS. Mentor junior analysts through hands-on training and data review. Join a dynamic team making a difference in patients’ lives.

Requirements

Expertise in HPLC-based analyte quantitation and release profiling
Proficiency in GC/MS for extractables and residual analysis
Experience with FTIR characterization and polymer analysis techniques
Ability to lead method validation (TMV), verification, and transfer activities
Skills in complex sample preparation across biological matrices, polymers, extracts, and device components
Technical troubleshooting and root cause investigation for analytical issues
Knowledge of FDA, ICH, ISO 17025, and internal QMS requirements
Experience mentoring junior analysts and providing technical guidance

Responsibilities

Serve as 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