Process Supervisor

GEORGE A. TOROPIW

* ****** ******

South River, New Jersey 08882

Home 732-***-**** *******@***.***

Cell 732-***-****

SUMMARY

A results-oriented, resourceful PROCESS SUPERVISOR with extensive

processing experience in the manufacture of Pharmaceuticals, Fine

Chemicals, and Biologics. Strong FDA, DEA, cGMP, ICH, SAP, Delta V, SOP,

EPA, and OSHA regulatory compliance experience. Excellent analytical,

interpersonal, and leadership skills.

PROFESSIONAL EXPERIENCE

Bristol Myers Squibb, New Brunswick, NJ

1999 to 2013

Lead Shift Supervisor, Pharmaceutical Development Pilot Plants

2011 to 2013

Managed 4 unionized Process Development Technicians and 3 Process

Supervisors in the operation of solids charging, Hydrogenation, batch

reaction, high pressure chromatography, distillation, crystallization,

filtration, centrifugation, drying, milling, and blending of product

intermediates and final Active Pharmaceutical Ingredients (API).

. Wrote Delta V recipes and oversaw the scale-up process for new

compounds destined for toxicology studies and clinical trials.

. Trained new process supervisors and process development technicians in

safety, equipment functionality, process flow, pilot plant utilities

systems, process software (Delta V), and inventory control system

(SAP)

. Authored work instructions (W.I.), job aids, and energy control

procedures (E.C.P.) for equipment used in 3 Pharmaceutical Development

Pilot Plants.

1. Member of 6 person team responsible for the interviewing and final

selection of all new Process Development Technicians (PDTs)

2. Member of Process Analytical Support Lab / Operations interface

team

3. Member of Environmental Health & Safety / Operations safety

committee

Lead Process Supervisor, Fermentation Pilot Plant 2009 to

2011

Supervised 3 unionized Process Development Technicians in the

operation of fermentation vessels from 20 liter to 1000 liter scale

and recovery equipment that included high speed centrifuges,

homogenizer, cell disruptor, cross flow filters, and ultra filters.

. Maintained equipment in a clean and process ready state

. Scheduled all Fermentation Pilot Plant experiments.

. Ordered and maintained inventory of required raw materials.

. Authored batch records and Delta V recipe driven procedures for all

experiments.

. Initiated and followed up on work orders for the repair and

servicing of pilot plant equipment.

. Trained all Process Development Technicians in the proper use of

all new equipment.

Process Supervisor, Pharmaceutical Development Pilot Plants

1999 to 2009

Supervise 2- 8 unionized Process Development Technicians in the

operation of solids charging, Hydrogenation, batch reaction, high

pressure chromatography, distillation, crystallization, filtration,

centrifugation, drying, milling, and blending of intermediate and

final API compounds.

. Maintained yields and quality at company standards while adhering to

all established FDA, DEA, cGMP, SOP, safety, and regulatory

specifications.

. Maintained and validated production records.

. Wrote Delta V recipe driven procedures for batch processes in the

pilot plants.

. Authored operation process summaries for all personally supervised

batch campaigns

. Initiated and followed up on work orders for the repair and servicing

of pilot plant equipment.

GEORGE A. TOROPIW

Page Two

Home 732-***-**** *******@***.***

Cell 732-***-****

Purepac Pharmaceuticals, Elizabeth, NJ

1993 to 1999

Production Supervisor, Solid Oral Dosage

Supervise 4-20 unionized Chemical Operators in the operation of

material weighing, wet granulation, drying, milling, blending,

encapsulation, compression, and tablet film coating.

. Maintained yields and quality at company standards while adhering

to all established FDA, DEA, cGMP, SOP, safety, and regulatory

specifications.

. Maintained and validated production records.

. Initiated and followed up on work orders for the repair and

servicing of manufacturing equipment.

EDUCATION

B.S. Degree Biology, Rutgers University, Piscataway, NJ

PROFESSIONAL DEVELOPMENT

Rockhurst University Continuing Education Center, Woodbridge, NJ

Completed "Coaching and Mentoring Skills for Managers and Supervisors"

(0.6 CEUs)

Fisher-Rosemount Educational Services, Allendale, NJ

Completed "Delta V Operate Implementation" (3.2 CEUs)

Center for Professional Advancement, East Brunswick, NJ

Completed "Pilot Plant Studies and Process Scaling" (2.4 CEUs)

University of Wisconsin, Madison, Wisconsin

Completed "Chemical Engineering Unit Operations" (2.1 CEUs)

Center for Professional Advancement, East Brunswick, NJ

Completed "Granulation, Tableting, and Capsule Technology" (2.4 CEUs)

Center for Professional Advancement, East Brunswick, NJ

Completed "Current Good Manufacturing Practice (cGMP) for

Pharmaceutical Production Supervisors" (1.8 CEUs)

American Management Association, New York, NY

Completed "Communicating with Diplomacy and Tact" (1.2 CEUs)

IWCC Training In Communications, Cranford, NJ

Completed "Technical Report Writing" (1.5 CEUs)

Pennsylvania State University, State College, Pennsylvania

Completed "Fermentation Methods and Scale-up Strategies" (2.8 CEUs)

Pennsylvania State University, State College, Pennsylvania

Completed "Separations and Purification Strategies for Biotechnology

Products" (3.6 CEUs)

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