Medical Device Chemist: NVR & Extractables (Contract)

Actalent; Fridley (MN); On-site; USD 39,000 - 40,000; Full time

Benefits offered by this job

Medical

Dental & Vision

401(k) Plan

HSA

Job summary

Actalent is seeking a Medical Device Chemist to perform NVR analyses, extractions, and sample preparations in a rigorous analytical chemistry lab supporting the medical device field. You will work within ISO 17025 and ISO 10993 Part 18 frameworks, handling validated methods and instrument setups in a hands-on environment.

The role requires a Bachelors in a technical discipline and extensive experience in analytical labs, with on-site work in Fridley, MN.

Qualifications

• Bachelor's degree in chemistry, biology, materials science, or a related technical discipline.
• 13 years of industry experience in an analytical or materials-focused laboratory setting.

Responsibilities

• Perform Non-Volatile Residue (NVR) analysis, extractions, and detailed sample preparation in an analytical chemistry lab.
• Execute validated test methods for extraction studies and sample preparations in accordance with established protocols and ISO 17025 and ISO 10993 Part 18 requirements.
• Set up, operate, and maintain analytical instrumentation required for chemical characterization testing.
• Document all testing procedures, observations, and data analysis results clearly and accurately in a lab notebook and laboratory information management system (LIMS).
• Support investigations into aberrant or out-of-trend test results by assisting with root cause analysis and follow-up testing.
• Test research and development (R&D) samples based on experimental plans or in consultation with laboratory personnel.
• Establish, communicate, and adhere to timelines for test completion to help the analytical lab team meet business and project targets.
• Contribute to continuous improvement by supporting updates, refinements, and reviews of laboratory processes and workflows.
• Apply harsh solvent extraction methods to medical devices to mimic extended use conditions and evaluate extractables such as oils, ethylene oxide (EO), metals, and plastics.
• Ensure all work complies with relevant cGMP, FDA, ICH, and ISO standards and internal quality procedures.

Skills

NVR analysis

ExTrac tions

Sample preparation

Analytical instrumentation

Education

Bachelor's degree in chemistry, biology, materials science, or related

Tools

LIMS

Analytical instruments

Job description

Actalent is seeking a Medical Device Chemist to perform NVR analyses, extractions, and sample preparations in a rigorous analytical chemistry lab supporting the medical device field. You will work within ISO 17025 and ISO 10993 Part 18 frameworks, handling validated methods and instrument setups in a hands-on environment.

The role requires a Bachelors in a technical discipline and extensive experience in analytical labs, with on-site work in Fridley, MN.