Description
Seek position in R&D as a analytical development team leader handling multiple projects, coordinate project activities with various departments (quality assurance, Reg. CMC, Clinical Manufacturing Unit, Drug supply management, technical operations and outside contract laboratories. Direct analytical method development and oversee analytical development for the formulation development at contract labs
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| (Confidential) | Consultant Compliance And Regulatory Affairs | 1/2015 - Present |
| Impax Labs | Quality Consultant / Chemistry Technical Writer | 3/2014 - 8/2014 |
| Novartis Pharmaceuticals | Principal Scientist/Analytical Project Leader, Analytical R&D | 1/2000 - 12/2013 |
| Bristol Myers Squibb | Senior Research Scientist, Analytical And Formulation R&D | 11/1996 - 12/1999 |
| Gensia Laboratory Ltd. | Research Investigator, Analytical R&D | 3/1996 - 11/1996 |
| Abbott Labs | Research Scientist, Analytical R&D | 1/1989 - 3/1996 |
| Us Gypsum Research Center | Technical Staff Member | 7/1981 - 12/1988 |
Accomplishments
Highlights:
Filed 3 ANDA'S at BMS, 1 NDA at Abbott Labs and 6 IND's and 4 NDA at Novartis Pharmaceuticals Corp. Developed 30 HPLC methods for better sensitivity, better resolution between degradation products peaks and short run time to increase throughput
Job Skills
Keywords
Responsibilities
With over 15 years experience in analytical research & development in pharmaceutical industry I have well diversified knowledge and understanding to handle responsibilities related to this position. I bring in extensive pharmaceutical experience in analytical research and development for drug substance and drug products in a cGMP environment with thorough understanding of ICH and FDA guidelines.
I have strong project management and interpersonal skills and thorough understanding of pharmaceutical development processes, quality risk management and GLP/cGMP. Coordinated and overseen analytical development at contract labs with track record of meeting extremely tight timelines
I have expertise in method development, validation, method transfer, stability, setting and implementation of specifications for APIs and finished drug products, quality by design (QbD) strategy for drug development and change control.
I have integrated/reviewed analytical data for the preparation of Reg CMC documentation for filing IND and NDA for Europe and US and answered health authority questions to FDA and EMEA.
I am looking forward to working with a team of dynamic individuals in a well reputed and leading pharmaceutical company.
