KRZYSZTOF KOWALCZYK

* ******** ****, ******* *.J. 07747

Tel . - 732-***-**** E - Mail - accero@r.postjobfree.com

QUALIFICATIONS:

** ***** ********** ** *** Pharmaceutical industry.

Extensive knowledge of the various pharmaceutical manufacturing equipment and

processes.

Expertise in the Fluid Bed process scale up and optimization.

Documentation, batch records and extensive knowledge of F.D.A./G.M.P.'s and

D.E.A. regulations.

Knowledge of MS Word/Excel and familiar with the most widely used computer programs.

Excellent work ethics and attendance records.

WORK HISTORY:

01/2010 - 02/2013 NOVARTIS Pharmaceutical Corporation

Sandoz R&D East Hanover N.J.

Lead Pilot Plant Technician

•Work with scientists for the development of new/modified formulations within R&D Pilot

plant.

•Set up and operate various pharmaceutical equipment - this include but not limited to :

•Fluid Beds (Glatt), Compression (KORSCH, FETTE, Globe Pharma), Milling

(Fitzmill,Conmill)

•Coating (O'HARA, GLATT Mini ), Blending and Granulation (Gral), Compacting (Fitzpatrick)

•Process characterization including bulk density, particle size analysis using ATM sonic

shifter.

•Accurately dispense raw materials and prepare coating/drug solutions .

•Document in lab notebooks and batch records and maintain all entries as per

•GMP’s and SOP’s requirements. Maintain records and clean room environment to comply

with regulatory requirments. (FDA and DEA ).

•Maintain all Pilot Plant equipment in the working order.

Assist scientists in Bio equivalent studies and subsequent ANDA submissions

•Adhere to all environmental, occupational, safety and health (OSHA) requirements

•Perform and assist other technicians with writing all new S.O.P. s .

•Support scientists daily with the improvements and process optimization.

03/2003 - 06/2009 Alpharma Pharmaceuticals LLC

Piscataway/Elizabeth, N.J.

Senior Technician

• Work with scientists for the development of new/modified formulations within R&D Pilot

plant.

• Set up and operate various sizes of the GLATT Fluid Beds GPCG-3-5-15-30 and other

related pharmaceutical equipment for development and clinical batches.

• Supported and executed various exhibit batches including KADIAN® and EMBEDA™.

• Accurately dispense raw materials for all experimental and clinical/exhibit batches.

• Prepare coating/drug solutions and dispersions for all runs on the fluid beds.

• Perform verification cleaning as needed and maintain daily cleaning of all equipments

within the pilot plant.

• Document in the lab notebooks and batch records and maintain logbooks entries as per

GMP’s and SOP’s requirements.

• Maintain Pilot plant clean and organized in the compliance with cGMP's, FDA, DEA,and

OSHA requirements.

• Perform physical testing and routine sampling as needed for all experimental/clinical

work.

• Maintain inventory and records of the all DEA and non DEA raw materials and batches

• Support scientists with the process improvement and optimization.

• Perform rejects procedures of the all rejected batches and raw materials.

• Operating and trouble shooting MG Futura Encapsulation Equipment.

09/2000 - 02/2003 Nobel Biocare Fair Lawn, N.J.

Technician II/Group Leader

• Responsible for all phases of the computerized production of the ceramic crowns.

• Operated ultra modern automated computerized equipment.

• Performed milling, casting, sintering, and in process control involving microscope and

measurement instruments.

• Filling the batch records following cGMP’s and SOP’s.

• Quality Control and the batch record reconciliation.

• Effectively managed crew to optimize volume of the production.

• Interfaced with department and QA Management resolving product quality issues.

2/1997 - 8/2000 Schering Plough Kenilworth, N.J.

Technician I

• Set-up and operated various pharmaceutical equipment and packaging production lines.

• Documentation, maintain log books entries and filling batch records following GMP’s and

SOP’s.

• Optimized equipment performance by adhering to specification of the SOP’s.

• Perform physical testing and routine sampling.

• Performing Group Leader function as back up when needed.

• Operated following manufacturing equipment:

Milling - Fitzmill, Comill

Blending - V-Blender,Grall

Coating - Accela cota and Hi-coater

Drying - Ovens,Fluid bed dryer

Packaging - Marchini Packaging bottle fillers and lines

• Ensured proper calibration and documentation of the scales,mfg.equipment,

and temperature/humidity recorders.

03/1990 - 10/1996 Lohmann Therapy Systems West Caldwell, N.J.

Technician II

• Responsible for Set Up/Operate computerized Transdermal Delivery System equipment

and Vertical Packaging machines, including necessary change over’s.

• Completed 2 months training in Germany involving transdermal technology and in

process control. (QC)

• Responsible for random sampling of the HABITROL™ patches.

• Accurate measurement of the oxygen level of the pouch using lab instruments, and

accurate weighing nicotine level of the patch.

• Make necessary adjustments to the equipment to maintain high quality of the products.

• Preparation and filling the batch records, labeling, deviations, and reconciliation of the

entire batch.

• In process control. (QC) Supported and participated in all PQ/EQ runs.

• Documented all activities associated with work orders and equipment corrective

maintenance.

• Processed rejection and disposition of the labels and other products (liquid form)

in compliance with FDA and OSHA regulations.

• Adhered to environmental,occupational,safety and health (OSHA) requirements

while meeting or exceeding production goals and quality standards.

EDUCATION and TRAINING

High School - Wroclaw, Poland

College - Associate Degree - INSTYTUT TECHNOLOGII - Wroclaw, Poland

TRAINING and SEMINARS

MG America

Glatt Wurster and Rotor seminar

Colorcon Coating Technology

REFERENCES - Available upon request

Contact this candidate