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Flemington, NJ, 08822
... Drug Substance Plant management responsibilities for the daily operations of a start-up pharmaceutical manufacturing facility with 15 formulations and 25 OTC finished products of children cold and cough syrups, suspensions, and nasal sprays. ...
- 2011 Oct 17
East Windsor, NJ, 08520
... • Maintained Receipt, Usage log and inventory of Controlled Substance/Reference Standard/Chemicals/Reagents and Equipment. • Managed Equipment Maintenance like PM, PT, OQ, PQ calibration schedule and performed Instrument HPLC, Dissolution etc. ...
- 2011 May 26
Fountainville, PA, 18923
... Thorough understanding of the drug development process, including all analytical support needed for initial drug substance through formulation development and ANDA filing. * Established new Analytical Lab for Sigmapharm Laboratories. Directed all ...
- 2011 Apr 19
Manville, NJ
... Ensured all work performed in compliance with cGMPs, company policies and procedures, and applicable regulatory requirements * Designed and developed analytical and QC methods for drug product analysis and drug substance characterization; HPLC and ...
- 2011 Jan 05
Morrisville, PA, 19067
... Maintained and organized shipping/tracking records, which were readily retrievable for in-house QA audits, corporate audits, and FDA inspections • Performed inspection of controlled substance with Corporate Officer and Control Substance Officer and ...
- 2010 Sep 01
Basking Ridge, NJ, 07920
... Department has overall responsibility for release of raw materials, bulk drug substance EXPERIENCE (CONTINUED) and finished products , analytical method development , validations and managing the stability program. Lead all corporate quality ...
- 2010 Aug 16
Plainsboro, NJ, 08536
... t2uau5@r.postjobfree.com Highly talented, enthusiastic and innovative analytical chemist with extensive pharmaceutical R & D experience in method development (HPLC, GC, UPLC) for drug products (Solid/Parenteral), drug substance and quantitation of ...
- 2010 Apr 12
Chalfont, PA, 18914
... Isolated a low level impurity (at 0.07% of drug substance) using at- column dilution, mass-driven collection and comprehensive automation of the entire process. This impurity was isolated with 91% purity allowing it to be characterized by NMR ...
- 2010 Mar 09
bridgewater, NJ, 08807
... “Kinetic Studies of the Formation of Potential Genotoxic Impurities in a Drug Substance”; 234th ACS national meeting, Boston, MA, August 19-23, 2007. REFERENCE Available upon request
- 2009 Nov 22