EDUCATION AND EXPERIENCE:

• M.S./Ph.D. in Chemistry or other related discipline and at least 1-2 years of relevant experience in the pharmaceutical industry preferred.
• In the case of highly skilled and experienced individual, a B.S degree with at least 7 years of experience may be considered with a track record of achievement.
• Hands-on experience and expertise in HPLC (reverse phase, ion exchange, ion pair, HILIC (hydrophilic interaction liquid chromatography), HPLC/MS/MS, Dissolution (USP Apparatus I and II), pH meter, Analytical Balances and wet chemistry desired.
• Experience with Agilent ChemStation and/or Waters Empower chromatography data acquisition software is required
• Ability to design, follow, and review experimental protocols, scientific methods, and departmental procedures is required
• Ability to organize and interpret scientific data is required
• Prior experience training and mentoring less experienced staff is desired

GENERAL PURPOSE OF POSITION:

This position is responsible for laboratory activities associated with analytical testing, analytical method development, and method validation. Interfaces with Product Development, Manufacturing and Quality Assurance functions to proactively fulfill analytical laboratory responsibilities and to perform QC analytical testing, leverage analytical sciences to characterize formulations under development and to provide analytical testing for the development of novel 3DP (three-dimensional printing) manufacturing processes. In addition, this position is responsible for writing protocols, development reports, SOPs, (standard operating procedures); training others on analytical techniques; being familiar with USP/NF (United States Pharmacopeia/National Formulary) analytical procedures; and maintaining an understanding of cGMP’s (current Good Manufacturing Practices) and ICH (International Conference on Harmonization) guidelines.

DUTIES/RESPONSIBILITIES

1

Perform GMP analytical testing, method development and validation of analytical methods utilizing a variety of analytical techniques including HPLC-UV (High Performance Liquid Chromatography – Ultra Violet Detector), UV-Vis (Ultra Violet-Visible) Spectroscopy, HPLC/MS/MS, GC, analyses using different separation mechanisms and Dissolution (Apparatus I and II)
2

Perform and monitor stability testing of drug products. Provide statistical analysis of the data when applicable.
3

Perform analytical testing in support of Product Development. Conduct data analysis and assess consistency/accuracy for development projects.
4

Perform technical problem-solving utilizing a background of wet chemical and instrumental methods of
analysis.
5

Transfer analytical methods and procedures between testing sites when applicable and provide guidance and technical support to laboratory staff for implementation.
6

Train and mentor less-experienced members of the QC/AD Department as needed.
7

Author analytical methods, SOPs, and technical protocols and reports
8

Adhere to all company compliance and safety procedures
9

Maintain a clean and safe workplace daily