Description
Key Responsibilities to Include:
- Perform structural elucidation (mass spectral interpretation) of data generated by a variety of analytical equipment as part of testing for Extractables and Leachables.
- Perform test method development, validation of test methods using various chromatographic-mass spectroscopic techniques (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
- Provide strategy on root cause analysis for product/sample failures and Out-of-Specifications (OOS), non-conformances, and CAPA and guide other chemists perform investigations
- Provide solutions and lead in the validation of new laboratory equipment
- Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures
- Perform testing as needed
Requirements
Basic Qualification Requirements
- Bachelor's Degree in Chemistry with minimum 10 years of related experience required
- Master's Degree in Chemistry with minimum 8 years of related experience required
- PhD in Chemistry with minimum 2 years of related experience required
Required Scientific Experience
- Proficient knowledge of theory and application in structural elucidation (mass spectral interpretation) using a variety of chromatographic techniques utilizing mass spectrometer(s) (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
- Proficient experience with test method development and validation using analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)) following ICH, FDA, and USP guidelines.
- Proficient experience with troubleshooting and qualifying analytical equipment (GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)).
- Experience in a regulated environment (FDA, DEKRA, etc.)
Other Skills and Experience:
- Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Excellent demonstrated problem-solving, organizational, analytical and critical thinking skills
- Ability to manage confidential information with discretion
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Work is performed independently and reviewed from a relatively long-term perspective for desired results
- Act as a resource for colleagues with less experience and may lead the work of project teams
Job Information
- Job ID: 69059952
- Workplace Type: Hybrid
- Location:
Draper, Utah, United States - Company Name For Job: Edwards Lifesciences
- Position Title: Senior Principal Chemist
- Area of Focus: GC-MS,LC-MS,Material Science,Polymers
-
Job Function:
Quality Control,
Res. & Dev. Scientist - Setting: Biotechnology
- Job Type: Full-Time
- Job Duration: Indefinite
- Min Education: BA/BS/Undergraduate
- Min Experience: 7-10 Years
- Required Travel: 0-10%
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