SUMMARY

Strong project management experience in Pharmaceutical, Nutraceutical and

Biotech industries with primary focus on development of new products and

enhancement of existing products with the goal of quality and cost

improvements.

QUALIFICATIONS HIGHLIGHTS

. Solid knowledge of cGMP/GLP product development including active

pharmaceutical ingredients (API's), tablets, hard shell capsules,

softgels, free flowing powders, lyophilized (freeze-dried) powders and

liquid finished products.

. Deep understanding and knowledge of laboratory analysis of raw materials,

in process and finished products, stability testing, specifications

development, organic and analytical chemistry, physical testing.

. Reviewed and authored validation and stability protocols and reports,

SOP's, analytical methods, deviations, investigations, CAPA's, CMC

sections of FDA IND/NDA/ANDA submissions, Master Batch records, and in-

process manufacturing limits.

. Extensively utilized flow-charts, design of experiment, data management,

statistical data analysis, failure investigations, lean manufacturing

principles.

. Proficiency with Microsoft Office. Experience with Microsoft Project.

. Strong mentorship abilities. Coached 6 project coordinators and over 20

chemists in cGMP product development.

PROFESSIONAL EXPERIENCE

CODY LABORATORIES (LANNETT API), CODY, WY

QC Senior Chemist (2012-2014)

. Performed QC testing per USP and internal SOP's.

. Participated in waste elimination program per lean

manufacturing/services principals.

. Implemented E-Board, Kanban, and six other waste elimination

processes.

. Expanded QC lab to double the room size and sample throughput.

natures products, sunrise, FL

Product Development Manager/Lead scientist (2010-2012)

. Lead product development for nutritional powders, multivitamin tablets

and capsules.

. Liaised with IT, Costing, Sales, QA, QC and Manufacturing to ensure

smooth operations and introduction of new products throughout the

organization.

. Wrote piloting instructions and revised over 300 manufacturing master

batch records.

. Guided Label review for technical accuracy and compliance.

. Supervised one Sr. Formulation Scientist and one Jr. Formulation

Scientist.

. Quadrupled product development output with the same personnel since

started.

Azopharma, Miramar, FL

Project Manager/Supervisor/Lead Scientist (2005-2010)

. Provided technical guidance and support in the areas of Formulation

Development, Analytical R&D and Quality Control at CRO/CMO.

. Implemented and supported cleaning verification program and trace

analysis for the manufacturing equipment in multi-drug product

environment of CMO.

. Supervised 2 project coordinators, 3 chemists and one microbiologist

at a time.

Quintiles, Analytical Chemistry and Biotechnology, Kansas City, MO

Research Specialist (2003-2004)

. Lead GXP Formulation Support and Pre-formulation Studies for liquid

pharmaceutical biotech products in support of regulatory submissions

and pharmacokinetic studies in CRO environment.

Albany College of Pharmacy, Albany, NY

Instructor (2000-2001)

. Provided instructions for class of 106 students in organic chemistry

and NMR-, Mass-, and IR-spectra interpretation.

Albany Molecular Research, Inc., Analytical Services, Albany, NY

RESEARCH CHEMIST II (1997-1999)

. Developed and validated HPLC and other analytical methods for test

drug substances and intermediates for internal and CRO customers.

PeproTech Inc., Rocky Hill, NJ

Research Scientist (1994-1997)

. Established and maintained Master File Library for over 100

genetically engineered products.

. Developed folding and purification procedures for recombinant proteins

resulted in successful addition of more than 10 new products to the

catalog, and over 300% revenue growth.

Sigma-Aldrich, Dept. of Bioactive Peptides, Rehovot, Israel

Development Chemist (1989-1994)

. Developed lab scale manufacturing processes and executed separations

and isolations over 100 of synthetic polypeptides by Preparative HPLC.

Vitamins Research Institute, Moscow, Russia

Organic Chemist/Engineer (1979-1989)

. Improved two steps in the manufacturing of Riboflavin (vitamin B2).

Participated in writing of Russian equivalent of Drug Master File.

. Wrote and successfully defended two patent applications on behalf of a

team.

EDUCATION

. M.Sc. in Chemistry and Chemical Engineering of Biologically Active

Compounds, Moscow Institute of Precision Chemical Technology, Moscow,

Russia. M.Sc. Thesis: "Opium Alkaloids from Tissue Culture of Papaver

Somniferum. Isolation, Identification and GC Analysis".

. Leadership training. Negotiation strategies. Harvard Law School

professional development program.

. PMP certification in-progress.

AWARDS

Two patents for vitamin E process development.

PROFESSIONAL AFFILIATIONS

American Chemical Society, PMI

US Citizen

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