A Chemist I must demonstrate a high level of initiative and self motivation, be adaptive, flexible, capable of operating effectively within a team-oriented environment, and able to balance multiple priorities in a time sensitive work environment. The quality and results of your work will support the stability evaluation and release of finished products for Clinical studies, ANDA filings, and an improved quality of life for our customers.

Responsibilities:

• Follow the guidance and instruction of Supervisors and trainers.


• Work closely with Supervisor to monitor test progress and results.


• Follow FDA GMP guidelines and company SOP’s.


• Support a culture of “quality” in the laboratory environment.


• Prepare samples for testing as well as the Standards used for testing.


• Perform dissolution testing by HPLC or UV methods which includes: alcohol study, media comparison, etc.


• Prepare buffers, mobile phases, diluents.


• May perform cleaning validation using HPLC and UV methods.


• Learn to maintain the HPLC system and dissolution bath.


• Must learn to perform Solubility, Potency Assay, Blend Uniformity, Content Uniformity and Impurities testing by HPLC.


• May perform GC, FTIR, UV/Vis, IC, TLC and/or other wet chemistry techniques as instructed.


• Record test results in Lab Notebook.


• Support projects as directed that lead to clinical studies and/or to the filing of ANDA’s.


• Must organize work and budget the use of time in order to be efficient and results oriented.


• Other tasks as needed in the R/D Lab.

Requirements:

• BS degree in science related field; one with chemistry degree is preferred; other field such as Biology major with equivalent chemistry background may also qualify.


• Must have strong mathematical skills and experience of basic wet chemistry techniques.


• Must have computer skills; Microsoft Word, Excel.


• Must be able to communicate in English both verbally and in writing.


• R&D environment may require occasional work at night or on weekends.


• Must be able to push, pull and occasionally move 50 lbs (dissolution containers)