Principal Chemist
FUNCTION:
Serve as primary expert in mass spectrometric analysis of customer samples. Provide technical leadership, evaluate and institute new technologies relevant to qualitative and quantitative analysis and identification of unknowns, manage projects, provide technical assistance within and external to the department.
ACCOUNTABILITIES:
List detailed duties of the role
1. Perform LC/MS and GC/MS analysis of polymers, polymer related samples, and trace components in pharmaceutical and biopharmaceutical sample matrices
2. Analyze and interpret mass spectral data of known and unknown compounds employing a variety of mass spectrometric techniques.
3. Be an expert on the various mass spectrometry techniques available in the laboratory and make recommendations for improvements.
4. Use mass spectrometry instrumentation both qualitatively and quantitatively where appropriate.
5. Keep current with new analytical technology and recommend acquisitions where appropriate.
6. Perform chromatographic analysis of samples as required.
7. Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
8. Prepare technical reports based on data from multiple analysts utilizing multiple analytical techniques.
9. Prepare work instructions, SOPs, and qualification documentation.
10. Design lab studies and prepare study plans and protocols.
11. Willingness to learn and apply new analytical techniques.
12. Perform lab, OOS, and OOT investigations as required.
13. Mentor others and provide technical direction. Provide leadership for cGMP compliance and technical training.
14. Serve as a role model for positive leadership.
15. Assist in meeting departmental goals.
The job descriptions reflect the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.
Requirements:
BASIC QUALIFICATIONS:
Experience:
Minimum of a BS degree in Chemistry or related field, advanced degree preferred
Minimum 10 years experience with mass spectrometry, especially LC/MS and GC/MS
Minimum 5 years GMP experience required, 10+ years experience strongly preferred
Significant experience in structural elucidation required
Experience with MS Chemstation required
Experience with MassLynx strongly desired
Strong oral and written communication skills and attention to detail required
Experience with SPE strongly desired
Method development experience strongly desired
Strong knowledge of mass spectrometric analysis of polymer desired
Strong background in chromatography desired
Knowledge of compendial testing desired
Experience with Empower desired
Experience in trace level analysis of small molecules in complex sample matrices, especially proteins and polymers