Analytical Chemist

Job Title: Analytical Chemist

Location: Arden Hills, MN

Employment Type: Long Term Contract

Department: Research & Development / Quality / Analytical Services

Job Purpose

The Analytical Chemist will support chemical characterization testing of medical devices, applying strong chemistry fundamentals in sample and standard preparation. The role requires operation and data interpretation of advanced analytical instrumentation including FTIR, GC-MS, LC-MS, and ICP-MS. This position plays a key part in ensuring regulatory compliance and product quality through accurate and thorough analytical testing.

Key Responsibilities

• Perform hands-on testing in the analytical chemistry lab, including:

• Sample preparation (extraction, solvent exchange, concentration)

• Gravimetric analysis for non-volatile residue

• Preparation of analytical standards and solutions

• Support the development, validation, and qualification of analytical methods

• Prepare analysis summaries and technical documentation to communicate findings to stakeholders

• Complete and maintain analytical lab documentation and quality records in compliance with regulatory requirements

• Assist with the qualification, calibration, and routine maintenance of laboratory instrumentation

• Conduct general lab support activities, such as ordering supplies, washing glassware, and monitoring lab conditions

• Apply scientific knowledge and company SOPs to evaluate data and solve technical problems

• Maintain strict adherence to ISO 10993, ISO 17025, FDA, and other applicable regulatory standards for medical device testing

• Demonstrate a strong commitment to patient safety and product quality by maintaining compliance with the company's Quality Management System (QMS)

Quality Systems Duties and Responsibilities

• Ensure quality is built into all work processes by complying with internal quality requirements and external regulatory standards

• Document all work according to Good Laboratory Practice (GLP) and relevant quality guidelines

Minimum Qualifications

• Bachelor's degree in Chemistry or related scientific discipline

• 0-2 years of relevant experience (recent graduates with internship experience are encouraged to apply)

• Experience with preparation of laboratory samples, standards, and solutions

• Strong written and verbal communication skills

• Excellent organization and documentation skills

• Ability to work collaboratively in a team-oriented lab environment

Preferred Qualifications

• Familiarity with Chromatography Data Systems (CDS)

• Prior experience with chemical characterization per ISO 10993 standards

• Hands-on experience with HPLC and/or GC systems, including method troubleshooting

• Experience working in a regulated environment (FDA, ISO 17025)

• Previous analytical lab experience in medical device or pharmaceutical industries

• Exposure to investigative and characterization analysis using chromatography or mass spectrometry

The law requires employers with 30 or more employees at one or more sites in Minnesota to disclose in each job posting the starting salary range and a general description of all benefits and other compensation including health or retirement benefits, bonuses, or other financial benefits to be offered.

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