- Bharat Adarkar has over 20 years of experience in packaging development, validation, and technology transfer for pharmaceutical, medical device, and consumer products industries. - He held senior roles at various companies where he led packaging engineering, validation, and global technical services teams. - Adarkar has extensive experience with packaging development and validation of oral solid dosages, injectables, liquids, ointments, creams, and medical devices across various markets and geographies.

1. BHARAT S. ADARKAR
“ Dilkoosha ”, First Floor
Altamount Road
Mumbai, 400-026
Home: 23510135 / Mobile: 99209 64346
E- Mail: bharat2126@yahoo.com
Public Profile: http://www.linkedin.com/in/bharatadarkar
OBJECTIVE:
To obtain a senior level packaging, validation, technology transfer or manufacturing position in the
pharmaceutical, medical device or consumer products industry.
SUMMARY:
• MS in Materials Science & Packaging Engineering and BS in Pharmacy with over 20 years
of professional experience in pharmaceuticals, medical devices and consumer products
• 20 years packaging validation, PAI Readiness and Technology Transfer experience of Oral Solid
Dosages, Injectables, Liquids, Ointments & Creams of pharmaceuticals & medical devices in
USA, Europe and Asia
• 10 years packaging development experience of medical devices, pharmaceuticals and consumer
products
• 5 years production operations, marketing and sales experience of pharmaceuticals and consumer
products
• Global Subject Matter Expert (SME) responsible for the co-ordination & approval of all packaging
validation functions of existing & new Technology Transfer products for FDA & Non-FDA
regulated Global Finishing Sites at Schering Plough Corporation in USA, Europe and Asia to
include Pre-Approval Inspection (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 500 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-60 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 as required
PROFESSIONAL EXPERIENCE:
2008 - 2008 Baxa Corporation, Englewood, CO
Packaging Engineering Manager – Process Excellence
Packaging Engineering Manager responsible for the initiation & start-up 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 & non-sterile medical devices.
• Active member of 3 Quality Systems Regulations (QSR) teams, being an alternate leader on the
Process Validation Team, responsible for rewriting and auditing all Quality Management System
Page 1 of 6

2. BHARAT S. ADARKAR
“ Dilkoosha ”, First Floor
Altamount Road
Mumbai, 400-026
Home: 23510135 / Mobile: 99209 64346
E- Mail: bharat2126@yahoo.com
Public Profile: http://www.linkedin.com/in/bharatadarkar
(QMS) documents to comply with FDA rules and regulations,. Our responsibility was to ensure
that all Quality Manuals (SOPs) were appropriately updated per FDA Regulations & met
requirements of FDA 483 Observations.
• Identified, interviewed & hired consultants to assist Baxa Corporation in updating Quality Manuals
to meet FDA 483 Observations.
2003 - 2007 Schering - Plough Corporation, Kenilworth, NJ
Technical Manager – Global Technical Services
Global 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 Non-FDA regulated Global
Finishing Sites in preparation for Pre-Approval Inspection (PAI) Readiness, Technology Transfers and
Validation.
• During the consent decree, as an SME, I single handedly managed over 18 – 20 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 management.
• 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 site-to-site 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 30+ sites develop consistency & uniformity in the packaging
validation process.
• Spearheaded monthly Packaging Validation Tactical Ring Teleconferences and highly successful
annual Face-to-Face 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 validations internationally.
1993 - 2007 BSA Consulting Technologies, East Brunswick, NJ
Consultant
Clients served: Johnson & Johnson, Warner Lambert; Bristol-Myers Squibb Company; Lockwood
Greene; Rhone-Poulenc; 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 corporation.
• Developed & tested Primary, Secondary & Tertiary ' Second Generation ' packaging for Solids;
liquids & aerosols.
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3. BHARAT S. ADARKAR
“ Dilkoosha ”, First Floor
Altamount Road
Mumbai, 400-026
Home: 23510135 / Mobile: 99209 64346
E- Mail: bharat2126@yahoo.com
Public Profile: http://www.linkedin.com/in/bharatadarkar
• 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 9 bulk blending / packaging tanks by more than
60%, preserving over 30,000 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.
1999 - 2002 American Pioneer Electronics, Inc., East Brunswick, NJ
Global Marketing, Sales and Purchasing Manager
• Hands-on Global Manager of Marketing, Sales and Purchasing for electronic components and
integrated circuits; increased overseas and domestic sales significantly.
1997 - 1998 Becton Dickinson Infusion Therapy, New Providence, NJ
Package 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.
®
• Rationalized 20 TYVEK bags to 5 bags and developed ship testing procedure.
1988 - 1993 Johnson & Johnson - Ethicon, Inc., Somerville, NJ
Technical Services Engineer
• Technical Services Engineer responsible for validating and troubleshooting packaging processes,
materials and equipment for $800+ million division manufacturing Ethylene Oxide sterilized and
Cobalt-60 irradiated surgical products and medical devices.
®
• Developed, transportation tested and validated form / fill / seal process for TYVEK and overwrap
packages resulting in zero ( 0 ) non-conformances 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 50% in the first year, substantially exceeding targeted goal of 33%;
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 40%.
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4. BHARAT S. ADARKAR
“ Dilkoosha ”, First Floor
Altamount Road
Mumbai, 400-026
Home: 23510135 / Mobile: 99209 64346
E- Mail: bharat2126@yahoo.com
Public Profile: http://www.linkedin.com/in/bharatadarkar
• Project leader on multiple domestic and international task force teams that substantially reduced
launch times of new product introductions and process transfers.
1986 - 1987 Schering - Plough Corporation, Kenilworth, NJ
Production Operations Supervisor
• As Supervisor of Production Operations, consistently maintained production efficiencies at 100%
of set standards; Audited documents for GMP and FDA Compliance.
• Reduced operating costs by $250,000.00 by leading and participating in Profit Improvement
Programs, Work Quality Circles and Employees' Suggestion Plan.
• Successfully orchestrated union avoidance campaign in department.
1984 - 1986 IC Industries, Inc.: Signal - Stat Division, Somerset, NJ
Packaging Development Engineer
• Initiated, restructured & consolidated packaging of heavy-duty truck hardware, lighting and safety
devices for OEM and after-market consumers; Developed SOPs and BOMs; Audited documents
for compliance.
• Designed and transportation tested unique corrugated package for emergency light bar that
increased production 300%.
• Converted WCCNB cartons to mist gray chipboard cartons; rationalized packaging components
to realize annual cost savings in excess of $125,000.00.
• Introduced in-house Skin Packaging Program that reduced costs and improved control over the
operation.
1982 - 1983 American Cyanamid, Wayne, NJ
Packaging Development Engineer
• 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 $210,000.00 annually.
• Introduced in-house Film Wrapping Project that reduced costs and improved delivery time to
customers.
1977 - 1979 Forest Laboratories, Far Rockaway, NY
Production Operations Supervisor
• 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 300% by streamlining the weighing operations of APIs &
supplemental pharmaceutical ingredients.
EDUCATION:
1981 - Rutgers University MS - Materials Science and Packaging Engineering; Research Fellow
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5. BHARAT S. ADARKAR
“ Dilkoosha ”, First Floor
Altamount Road
Mumbai, 400-026
Home: 23510135 / Mobile: 99209 64346
E- Mail: bharat2126@yahoo.com
Public Profile: http://www.linkedin.com/in/bharatadarkar
1976 - Bombay University BS – Pharmacy
TRAINING COURSES:
1986 and 1990 Kepner-Tregoe Problem Solving and Decision Making (Problem Identification,
Root Cause Analysis, Problem Solving and Decision Making Skills)
1992 Management of the Diversity Process
AWARDS:
2006 Schering Plough Corporation Distinguished Contributors Award presented by CEO and Board of
Directors for successfully completing all Consent Decree assignments as scheduled
2004 Schering 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
MEMBERSHIPS:
2007 – 2008 Honored Member: Emerald Who’s Who for Executives and Professionals
2005 Life Member: American Association of Indian Pharmaceutical Scientists ( AAiPS )
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6. BHARAT S. ADARKAR
“ Dilkoosha ”, First Floor
Altamount Road
Mumbai, 400-026
Home: 23510135 / Mobile: 99209 64346
E- Mail: bharat2126@yahoo.com
Public Profile: http://www.linkedin.com/in/bharatadarkar
Personal Care Products Package Development, Validation and Technology Transfer
Experience
Listed below is some of my international experience with packaging components for personal care
products:
At American Cyanamid (Jacqueline Cochran & La Prarie), J & J, BMS, Warner Lambert, Carter Wallace I
was responsible for the packaging of high priced, international prestige fragrances and beauty care
products such as Pierre Cardin, Grey Flannel, Nina Ricci, Nikki de Sainte Phalle, Ives Saint Laurent,
Clairol Haircare Products (shampoos, conditioners, hair colorants, etc.), Ban & Arrid anti-perspirants &
deodorants, Pearl Drops toothpaste, etc. for the global market.
• Packaging included Glass & Plastic bottled fragrances with intricate Closures made of metalized
and/or electroplated PE, PP & Barax plastics.
• Samplers in vials; bottles with pumps for liquid fragrances and Hand & Body Lotions & astrin-
gents and mouth washes
• Large Flacons for cosmetic displays in High Priced Department Stores such as Neiman Marcus,
Macy’s, Bloomingdales, Sears, JC Penney, etc.
• Jars for ointments & creams
• PE & PP and Laminated Tubes with embossed / metalized labels for lotions, skincare astrin-
gents, toothpastes, etc.
• Uniquely designed push through, screw-on & roll-on Plastic containers & closures for solid, liquid
& gel type deodorant, lipsticks & roll-ons.
• Uniquely designed aerosol containers for liquid & powder spray deodorants
• Packaging of conventional soaps & soap on ropes, uniquely wrapped in cellular paper & further
labeled with gold metalized & laminated paper labels.
• Screw-on, flip top, push-full closures (plain, metalized or electroplated) for a variety of beauty
aids in bottles & tubes.
• Uniquely designed Set-up boxes for containing flocked & thermoformed styrene trays to hold vari-
ous combinations of beauty products such as bottled fragrances & soap, bottled fragrances & lo-
tions in tubes, etc.
• A variety of secondary packaging such as IPFCs (Individual Product Folding Cartons) made of
SBS paper or WCCNB with conventional printing with varnish or acetate lamination, metalized
printing & embossing, etc.
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7. BHARAT S. ADARKAR
“ Dilkoosha ”, First Floor
Altamount Road
Mumbai, 400-026
Home: 23510135 / Mobile: 99209 64346
E- Mail: bharat2126@yahoo.com
Public Profile: http://www.linkedin.com/in/bharatadarkar
• An assortment of tertiary packaging materials such as corrugated shippers made of a variety of
flutes to meet end requirements. eg “E” Fluted corrugate was used for printed store displays.
After American Cyanamid purchased La Prairie cosmetics I was entrusted with the technology transfer of
the entire packaging operation from Kansas City to New Jersey.
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