Located in Whippany,, NH
The Analytical Chemist will analyze raw material, in-process, finished products and stability samples assuring compliance with standard operating procedures, Compendia sources, Test methods and Protocols. The focus will be on finished product in most cases.
- With supervision, conducts routine and non-routine activities. Performs analytical testing of raw materials, in-process control materials, stability samples, and finished product (Commercial, Clinical and Registration Batches) using different analytical techniques.
- Diligently follow written laboratory protocols, guidelines, procedures and methods.
- Expected to utilize established scientific techniques to compile and analyze data.
- Ensure that products are being tested strictly under cGMP conditions and disposition is taken on time as per the committed production plan for every month.
- Ability to identify creative and innovative solutions of non-routine analytical tasks.
- Suggests improvements of laboratory testing procedures, techniques and/or instrumentation
- Performs other duties related to the position when required by laboratory management
- Proficient in the use of Empower
- Exposure to the basic theory and operating principles of HPLC, UV, FTIR, GC, and Malvern particle size analyzers.
- Other duties as assigned.
- Ability to independently prioritize workload.
- May work on multiple projects and group to ensure the desired outcome is timely.
- Consults with supervisor/management on decisions for all the issues.
- Recognizes problems or compliance issues and reports to management.
- Good written and oral communication skills. Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos.
- Experience in chromatography (e.g. HPLC with Empower data acquisition software, GC, FTIR, UV and wet chemistry)
- Knowledge of ICH, FDA, and DEA regulations.
- Demonstrate computer literacy with proficiency in Microsoft office software, Trackwise and Empower.
- Must be able to move about the facility
- Must be able to wear personal protective equipment
- Must be able to lift up to 25 lbs
- 2 years working in pharmaceutical manufacturing environment.
- Solid understanding of cGMP practices and concepts.
Express Office: Parsippany
140 Littleton Road
Parsippany, NJ 07054