Senior/Principal Analytical Chemist
Aeroflow Medical · Minneapolis, MN
FULL-TIME
Posted Sep 8, 2026
Job Description
Primary focus of this position is to develop and validate analytical methods, develop product specifications, manage stability programs, and assist with regulatory filings for a novel combination medical device. This is a hands-on position spanning aspects of pharmaceutical and medical device development.
Primary Responsibilities
- Manage and drive method development and validation using analytical instruments such as HPLC, FTIR, GC, UV Vis, Karl Fisher, particle size analysis, and dissolution apparatus
- Manage and conduct routine analyses and data processing
- Maintain and troubleshoot analytical instruments
- Manage contract labs to ensure successful test method transfers and product testing
- Communicate technical results and observations to the team and upper management
- Write plans, protocols, and reports to support regulatory filings
- Write submission document to support regulatory filings
- Support operations to bring device to commercialization
- Think creatively, problem solve, and develop innovative solutions based on sound scientific analysis
- Other duties as required in small company
Basic Qualifications:
· Four-year degree in Chemistry or Chemical Engineering
· 10+ years in analytical research and development with emphasis in analytical techniques and new product submissions
· 10+ years of hands-on experience using analytical instruments and conducting analysis.
Required Skills:
- Advanced understanding of pharmaceutical regulations and medical device regulations and standards
- Demonstrated project planning/management and product development skills.
- Advanced understanding of quality systems and change control
- Advanced knowledge of a wide range of analytical techniques including HPLC with Chromeleon (or equivalent) analysis software
- Advanced knowledge of bioanalytical test methods and validation
- Ability to execute controlled experiments with a strong attention to detail is essential
- Driven self-starter with capability to work independently as well as with a small work place team
Primary Responsibilities
- Manage and drive method development and validation using analytical instruments such as HPLC, FTIR, GC, UV Vis, Karl Fisher, particle size analysis, and dissolution apparatus
- Manage and conduct routine analyses and data processing
- Maintain and troubleshoot analytical instruments
- Manage contract labs to ensure successful test method transfers and product testing
- Communicate technical results and observations to the team and upper management
- Write plans, protocols, and reports to support regulatory filings
- Write submission document to support regulatory filings
- Support operations to bring device to commercialization
- Think creatively, problem solve, and develop innovative solutions based on sound scientific analysis
- Other duties as required in small company
Basic Qualifications:
· Four-year degree in Chemistry or Chemical Engineering
· 10+ years in analytical research and development with emphasis in analytical techniques and new product submissions
· 10+ years of hands-on experience using analytical instruments and conducting analysis.
Required Skills:
- Advanced understanding of pharmaceutical regulations and medical device regulations and standards
- Demonstrated project planning/management and product development skills.
- Advanced understanding of quality systems and change control
- Advanced knowledge of a wide range of analytical techniques including HPLC with Chromeleon (or equivalent) analysis software
- Advanced knowledge of bioanalytical test methods and validation
- Ability to execute controlled experiments with a strong attention to detail is essential
- Driven self-starter with capability to work independently as well as with a small work place team
Additional Details
- City
- Minneapolis
- State
- Minnesota
- Country
- US
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