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To obtain a senior
level packaging, validation, technology transfer or manufacturing
position in the pharmaceutical, medical device or consumer products
MS in Materials Science
& Packaging Engineering and BS in Pharmacy with over
years of professional experience in pharmaceuticals, medical devices
and consumer products
validation, PAI Readiness and Technology Transfer experience of Oral
Solid Dosages, Injectables, Liquids, Ointments & Creams of pharmaceuticals
& medical devices in USA, Europe and Asia
development experience of medical devices, pharmaceuticals and consumer
operations, marketing and sales experience of pharmaceuticals and consumer
Subject Matter Expert SME
responsible for the coordination & approval of all packaging validation
functions of existing & new Technology Transfer products for FDA
& NonFDA regulated Global Finishing Sites at Schering Plough Corporation
in USA, Europe and Asia to include PAI Readiness & Validation
Developed Packaging Validation
related guidance documents, training programs and templates at Schering
Plough Corporation for finishing sites in USA, Europe and Asia
Consulted for numerous pharmaceutical
Fortune companies in the capacity of a GMP auditor, packaging development
engineer and validation specialist for Oral Solid Dosages, Injectables,
Liquids, Ointments and Creams
Project Manager responsible
for the development and validation of PETG and PS blisters for Medical
Devices at Becton Dickinson Infusion Therapy
Validated packaging presentations
for Ethylene Oxide sterilized and Cobalt irradiated needles, sutures
and medical devices for Ethicon, Inc. and consumer products for American
Cyanamid and IC Industries
Excellent team player;
Work well with management, finishing sites personnel and vendors
Willing to travel extensively
Engineering Manager – Process Excellence
Engineering Manager responsible for the initiation & startup of
packaging development & validation program. Developed new
packaging, specifications & templates for new product development
of Hazardous Drug Handling HDH & existing medical devices; Reviewed
& approved validation protocols; Approved current vendors; Identified
& Sourced new vendors for sterile, medical device packaging.
Responsible for the development
of all packaging related SOPs, guidance documents & training programs
for sterile & nonsterile medical devices.
Active member of Quality
Systems Regulations teams, being an alternate leader on the Process
Validation Team. Our responsibility was to ensure that all Quality
Manuals SOPs were appropriately updated per FDA Regulations &
met requirements of FDA Observations.
Identified, interviewed &
hired consultants to assist Baxa Corporation in updating Quality Manuals
to meet FDA Observations.
Schering Plough Corporation, Kenilworth, NJ
Manager – Global Technical Services
Subject Matter Expert
SME in the Global Validation & Process Management Technical Services
Department, responsible for assisting pharmaceutical finishing sites
by developing, reviewing, commenting and concurring upon all solid dosage
and secondary packaging validation strategies, ranging studies and validation
protocols and completion reports for all FDA and NonFDA regulated Global
Finishing Sites in preparation for PAI Readiness, Technology Transfers
During the consent decree,
as an SME, I single handedly managed over – Technology Transfer
and Global initiative projects annually. All project deadlines
were met ahead of scheduled time lines. Thereby, all consent decree
initiatives were met as scheduled and Schering Plough did not pay any
fines. My contributions were appropriately recognized by corporate
Projects included but were
not limited to the validation of existing and new packaging processes
of solid dosage forms into bottles, conventional and cold formed thermoformed
blister presentations and all secondary packaging. The Technology
Transfer encompassed transfer and validation of existing drug products
from sitetosite and new drug products to US and international finishing
sites including Puerto Rico, Belgium, Canada, Japan and Singapore.
Developed a training program
for high level Packaging Validation SOP, a Guidance Document for Packaging
Validation Protocols & a corresponding Packaging Validation Protocol
Template. These documents assisted over + sites develop consistency
& uniformity in the packaging validation process.
Spearheaded monthly Packaging
Validation Tactical Ring Teleconferences and highly successful annual
FacetoFace Packaging Validation Tactical Ring Meetings attended by
International Finishing Sites, Global Supply Chain and Research Institute
representatives. These meetings developed transparency between
sites and corporate departments and facilitated uniformity in packaging
Technologies, East Brunswick, NJ
Johnson & Johnson, Warner Lambert; BristolMyers Squibb Company;
Lockwood Greene; RhonePoulenc; Fresenius Medical Care; etc.
As Project Leader, supervised
validation engineers to ensure adherence to an aggressive validation
schedule set forth by the client. Project encompassed validation of
a new facility and equipment for solid dosage products.
Supervised and reviewed protocols
to validate renovations of sterile filling rooms of a multinational
Developed & tested Primary,
Secondary & Tertiary ' Second Generation ' packaging for Solids;
liquids & aerosols.
Developed Packaging Component
Specifications and Standards; SOPs and BOMs; Interfaced with Subcontractors,
ensured smooth and timely launch of new pharmaceuticals including Class
II Drugs; Audited for GMP and FDA Compliance.
For dialysis fluids manufacturer,
incorporated continuous cost savings & increased production outputs
by reducing RO / DI water flushing of bulk blending / packaging tanks
by more than %, preserving over , gallons of unproductively exhausted
RO / DI water daily. In addition, local municipal authorities commended
manufacturer for reducing chemical waste disposal in sewers; Audited
documents for compliance.
Tested and approved packaging
components and participated in the establishment of formal documentation
procedure to expedite traceability of critical packaging components
for international pharmaceutical company.
Pioneer Electronics, Inc., East Brunswick, NJ
Marketing, Sales and Purchasing Manager
Handson Manager of Marketing,
Sales and Purchasing for electronic components and integrated circuits;
increased overseas and domestic sales significantly.
Dickinson Infusion Therapy, New Providence, NJ
Development Project Manager
Project Manager responsible
for the development and testing of unique PETG and PS blisters for second
and third generation Central Venous Catheters.
Developed SOPs and BOMs, specifications
and graphics of packaging components for Central Venous and Pulmonary
Arterial catheters manufactured in Singapore and UK.
Identified, tested and approved
new thermoformable plastic – PCTG; Designed and Developed new tray
for Pulmonary Arterial catheters.
Qualified new blister manufacturer
in Singapore. Redesigned existing blister and developed ship testing
procedure; Audited documents for GMP and FDA Compliance.
Served as special assignee
to Quality Director in Singapore compiled validation documentation
to meet FDA and transit test requirements and gap analysis report.
bags to bags and developed ship testing procedure.
& Johnson Ethicon, Inc., Somerville, NJ
Technical Services Engineer
responsible for validating and troubleshooting packaging processes,
materials and equipment for $+ million division manufacturing Ethylene
Oxide sterilized and Cobalt irradiated surgical products and medical
tested and validated form / fill / seal process for TYVEK®
and overwrap packages resulting in zero nonconformances due to
seal related defects, thereby reducing customer complaints significantly.
Received special commendation
from Vice President of Operations for eliminating ozone depleting chemicals
usage by % in the first year, substantially exceeding targeted goal
of %; Audited documents for GMP and FDA Compliance.
Designed, transportation tested
and validated several package configurations resulting in increased
product efficacy; reduced cycle times and operating expenses by %.
Project leader on multiple
domestic and international task force teams that substantially reduced
launch times of new product introductions and process transfers.
Plough Corporation, Kenilworth, NJ
As Supervisor of Production
Operations, consistently maintained production efficiencies at %
of set standards; Audited documents for GMP and FDA Compliance.
Reduced operating costs by
$,. by leading and participating in Profit Improvement Programs,
Work Quality Circles and Employees' Suggestion Plan.
union avoidance campaign in department.
Inc.: Signal Stat Division, Somerset, NJ
Initiated, restructured &
consolidated packaging of heavyduty truck hardware, lighting and safety
devices for OEM and aftermarket consumers; Developed SOPs and BOMs;
Audited documents for compliance.
Designed and transportation
tested unique corrugated package for emergency light bar that increased
Converted WCCNB cartons to
mist gray chipboard cartons; rationalized packaging components to realize
annual cost savings in excess of $,..
Introduced inhouse Skin Packaging
Program that reduced costs and improved control over the operation.
Cyanamid, Wayne, NJ
As Packaging Engineer, developed
cosmetic packages from initial concept to point of sale; sourced domestic
and international vendors; Audited documents for compliance.
Authored packaging specifications,
SOPs and Bills of Materials.
Frequently interfaced with
suppliers, purchasing, marketing, manufacturing and R & D groups.
Developed and implemented
cost reduction program for cosmetic packages that realized savings in
exceeding $,. annually.
Introduced inhouse Film Wrapping
Project that reduced costs and improved delivery time to customers.
Laboratories, Far Rockaway, NY
As Supervisor of Production
Operations in the raw materials department of controlled & prescription
pharmaceuticals & OTC vitamins & mineral supplements, efficiencies
& outputs of the department were increased % by streamlining
the weighing operations of APIs & supplemental pharmaceutical ingredients.
Rutgers University MS
Materials Science and Packaging Engineering; Research Fellow
Bombay University BS Pharmacy
Plough Corporation Distinguished Contributors Award presented by CEO
and Board of Directors for successfully completing all Consent Decree
assignments as scheduled
Plough Corporation Appreciation Award presented by CEO and Board of
Directors for successfully completing the Technology Transfer of Ezetimibe
tablets from Puerto Rico to Singapore
– Honored Member: Emerald Who’s Who for Executives
American Association of Indian Pharmaceutical Scientists AAiPS