Seeking a candidate to handle the daily operation of Development and commercial reference standard program for Stability Group within Analytical Development function at client’s site.
- Coordinates with Analytical Project Leader to ensure timely qualification and requalification of Reference Standards or Reference Materials.
- Responsible for proper storage and inventory control of Reference Standards or Reference Materials in the designated secure area.
- Purchases, stores, and handles Reference Standards from compendia sources for routine use according to compendia instruction under the supervision of the Analytical Project Leader.
- Maintains inventory and list of Reference Standards and Materials.
- Distributes Reference Standards and Reference Materials to users, such as Laboratory Analysts and contract service providers.
- Sends notifications to Analytical Project Leader when the inventory is low.
- Disposes of remaining quantity of Reference Standards or Reference Materials from the designated secure area when the requalification is discontinued.
- Prepares Purity Statement based on qualification/ requalification data.
- Will report to Director Analytical Development.
- BS/MS Chemistry (Organic or Analytical) or relevant discipline with equivalent experience.
- Manager open to Ph.D. Chemistry candidates.
- Should have knowledge in the analytical testing required to generate reference standard purity statements
- Minimum 2 - 4 years recent cGMP/GLP pharmaceutical laboratory experience.
- Prior reference standard handling experience required.
- Good communication skills.
- Able to work well in team environment to achieve results.
- Exhibits sound scientific judgment based on reasonable assumptions and available information.
- This position required on-site presence, Mon-Fri.