Who We Are:
Analytical and Regulated Projects group within Department of Pharmaceuticals and Bioengineering Department supports the compliant and efficient operation of both analysis and GMP support for the department in addition to independent ongoing pharmaceutical operations. Objectives of this Role:
Daily and Monthly Responsibilities:
- Support analysis of various drug formulations utilizing HPLC, GC and dissolution instrumentation.
- Experience with chromatography systems and software, Empower/Waters and/or Agilent/chem station to carry out written procedures for a variety of dosage forms.
- Familiarity with cGMP documentation and USP guidance.
- Organize and schedule tasks to meet requirements for several concurrent projects.
- Experience with method development and validation of chromatographic analyses.
- Operate and maintain laboratory instrumentation, including basic troubleshooting and annual calibration.
- Maintain complete and accurate documentation of laboratory records and a clean and organized work area.
- Interact with clients to communicate and interpret results and overall program progress.
- Contribute to the preparation, review and execution of procedures and protocols.
- High attention to detail with regards to appropriate documentation and data packages and review of technical work.
- Requires a Bachelors with a 3.00 GPA in Chemistry degree
- 2-5 years: Hands-on experience, or other related lab experience with chromatographic systems to include HPLC, LCMS, GC, or GCMS
- Experience in a regulated environment preferably cGMP/FDA
- Strong math, organizational, and communication skills required
- Ability to work in a close-knit group towards common objectives
- Ability to train junior staff as needed
- Ability to Interact with division and institute QA as needed for compliant laboratory results
- A valid/clear driver's license is required
Must be a U.S. citizen or Permanent Resident due to ITAR work in section.