Analytical Chemist

Perform targeted analyte content and release/elution testing using validated HPLC methods and other routine analytical techniques, including GC, FTIR, and 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 Good Documentation Practices, ensuring complete and audit-ready records

Receive, log, label, and sequence samples correctly within analytical batches

Escalate deviations, instrument issues, or atypical results promptly to supervisory staff

Support test method validation and method transfer activities as assigned

Maintain laboratory cleanliness, chemical inventory, safe practices, PPE compliance, and QMS procedures

Participate in required training, cross-training, and competency assessments

Support R&D, Manufacturing, Quality, and Biocompatibility groups within Analytical Chemistry Shared Services

Support uninterrupted laboratory operations and successful TMV execution at the Lab Supervisor’s direction

• 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
• 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., Chem Station, 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
• Ability to foster a positive culture of growth, collaboration, and achievement
• Ability to follow FDA, ICH, ISO 17025, and internal QMS requirements
• Ability to work in an office and laboratory environment
• Willingness to travel as required (up to 5% stated in working conditions; 10% in job details)

Demonstrates expertise in analytical chemistry testing, particularly with HPLC and GC-MS instrumentation, while ensuring compliance with FDA, ICH, ISO 17025, and internal QMS requirements. Proficient in sample preparation, data review, and maintaining laboratory standards in a regulated environment.

• HPLC Instrumentation
• GC-MS Instrumentation
• Analytical Sample Preparation
• Regulated Laboratory Experience
• Good Documentation Practices

• HPLC
• GC
• FTIR
• GPC
• Analytical Chemistry Testing
• Chromatographic Methods
• Spectroscopic Methods
• Data Review
• System Suitability Checks
• Method Validation

• Attention to Detail
• Effective Communication
• Team Collaboration
• Interpersonal Skills
• Ability to Prioritize

• FDA
• ICH
• ISO 17025
• QMS
• Biocompatibility
• Medical Device
• Pharmaceutical

• Chem Station
• LIMS
• Excel