Scientist, Analytical Chemistry
Newark Metro Area, NJ
Responsible for references standard management, review data from contract service providers (CSP), help with trouble shooting and investigation, assisting in routine and non-routine sample analysis for drug substance and drug product, independently generate analytical protocol, data, reports. Well organized, multi-tasking and good communication skills with results driven actions.
Responsibilities will include, but are not limited to, the following:
Managing and overseeing the work from contract manufacturing and contract testing lab for pharmaceutical drug substance and drug product analysis
Adhere to all pertaining compliance requirements.
Review data from CSP, and communicate with CSP for data, our request, their practice, and following up actions.
Provide expertise opinion and direct CSP on investigations of drug product and drug substance analysis, authoring investigation reports.
Perform sample analysis as required.
Reference Standard Management
Reference standard qualification protocol, report, CoA writing and reviewing
Co-ordinate CSP to ensure timely qualification of reference standard
Performs reference standard qualification/requalification tests according to SOP and protocols.
Communicate reference standard internal and external users of changes and updates in qualification status and updates on references standard material.
Expertise in HPLC, GC, FT-IR, KF etc. required.
Experienced in managing and communicating with contract service provider.
In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidance a must.
Familiar with USP and other compendia.
Working knowledge of Empower required.
Must have working familiarity with cGMP practice and safety awareness for analytical laboratories.
5+ years of working experience in pharmaceutical analysis.
Manager will consider PhD but it's not a requirement Bachelors or Masters are acceptable