Senior Principal Chemist

This is a new opportunity to join an expanding chemistry laboratory as a Principal Mass Spectrometry Chemist. The position will be primarily responsible for evaluating medical devices, as a Subject-Matter-Expert, for Extractables and Leachables using data generated by a mass spectrometer(s) (e.g., GC-MS(SQ), GC-MS(TOF), GC-MS(QTOF), LC-MS(TOF), and LC-MS(QTOF)). Additional responsibilities include developing and validating test methods using chromatographic and mass spectrometric techniques.

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

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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.