Skip links

GURVINDER SINGH

GURVINDER SINGH

PHARMA PRODUCT DEVELOPMENT EXPERT
Click Here to Download Details

SUMMARY PROFILE :

  • Result oriented Scientist & trusted people leader with broad Pharmaceutical R&D expertise across dosage forms viz. Solid Orals, Liquids,Semisolids, Injectables and manufacturing technology.
  • Over 27years professional experience having excellent track record of delivering technology ROI for products with high sales potential for Global markets including US/EU/Canada/Brazil /CIS / Russia /India & other Emerging Markets.
  • Have expertise in handling difficult to develop complex Generics, New FDCs, OTC & New delivery Systems filed as NDA & ANDA.
  • Have led teams of DF project management with cross functional teams from different functions; demonstrated excellent leadership, communication, people management skills and computer skills/knowledge.
  • Successfully managed technology transfer of products developed in Lab to commercial scale in both InHouse & Outsourced locations.Developed technologies for first time viz. Hot Liquid filling in HGC, Hot Melt Extrusion & Protein Supplement based product equivalent to major brand being marketed worldwide.
  • Taken up priority projects with stringent timelines & delivered as per targeted schedules at both inhouse & outsourced manufacturing locations.
  • Successfully developed injectable products for USA market first time at Ranbaxy. These injectables include Dry Powder, Liquid & Lyophillized products including FTF/Para IV & transferred technologies at mfg site.
  • Intellectual Property and Regulatory experience through roles at Medreich, Ranbaxy, Dr Reddy’s, Dr Morepen & J.K. Pharma (now part of TEVA group).
  • Distinctive innovation track record: 10 granted/pending patents and 02 review articles.
  • Worked in different environments start ups, established professional and family owned business.
  • Capable of setting up green field projects in R&D

Key Skills/ Expertise

  • Preformulation Studies
  • Pharmaceutical R&D
  • Process development Studies based on QualitybyDesign & DOE concepts
  • Para 4 & 505(b)2 certification based filings
  • Technology Transfer Management
  • Troubleshooting & Reformulation
  • IVIVC
  • Regulatory Filing & compliance
  • Intellectual Property strategy

RESEARCH EXPERIENCE

  • Worked on development of Transdermal Drug Delivery System of Propranolol HCL project sponsored by University Grant Commission from 19881990 & work publilshed in ACTA PHARMACEUTICA Journal.

PROFESSIONAL EXPERIENCE

  • A.Currently providing overseas companies technical services in Global New product /Generic development & troubleshooting services.
  • B.Vice president F&D in Alembic pharmaceuticals (ARCHyderabad) Dec’2014 to Aug’2017

KEY ROLE & RESPONSIBILITIES

Involved currently in setting up new R&D Lab & Pilot scale GMP facilities as a ‘Greenfield Project’ for current organization suitable for development of oncology (Anticancer), highly potent drugs, colored compds containing projects & General category projects at Hyderabad. Subsequent of setting up of R&D site, heading this site & ensure development of new products for USA, EU, Canada & other regulated markets.

C. MEDREICH LTD. (Bangalore) Vice President R&D Oct 2013 to Oct 2014

KEY ROLE & RESPONSIBILITIES

Lead & develop a team of over 100 scientists for different R&D function viz. Product development, Process development, IP, Analytical research, Clinical bio pharmaceutics, Development Quality Assurance, Regulatory functions for the development of Novel & Generic products for EU/Canada & Emerging markets & technologies implementation to plant scale at bhouse manufacturing locations in the most efficient and cost effective manner.D. RANBAXY LABS (Gurgaon) Associate Director Pharma Research since July2006 to Sept 2013KEY ROLE & RESPONSIBILITIESLead & develop a team of GLs/SRSs to ensure new product filings and generate Intellectual Property & file new patents for innovative product / processes developed. This includes identifying new equipment and working in cross functional teams viz. Business, IP, Analytical research, Clinicalbio pharmaceutics, Quality, Manufacturing for the successful transfer of technologies to plant scale at both Inhouse & Outsourced manufacturing locations in the most efficient and cost effective manner.

KEY ACHIEVEMENTS

  • Successfully developed and launched new products for Rx & OTC categories
  • Successfully Developed technologies for first time viz. Hot Liquid filling in Hard Gelatin Caps, Hot Melt Extrusion based bilayered tablets & Protein Supplement based product equivalent to major branded product which has opened up opportunities for other unique products which would create immense value of approximately USD 300 million
  • Successfully developed injectable products and transferred to new manufacturing sites which has widened the product base and an opportunity for enhancing business & products in regulated markets including USA.
  • Successfully developed & obtained commercial approvals for various priority products despite tight / stringent timelines & delivered as per targeted schedules at both inhouse &outsourced manufacturing locations.

Reduced cost of equipment by 200% which also enhanced the quality of the product through the development of a local vendor for the production of the equipmentE.

DR REDDY’S LABS, A.P.

Associate DirectorFormulation Development July 2003 till 20thJul 2006

KEY ROLE & RESPONSIBILITIES :

Lead a team of CFT as part of Project Management for ANDA (Generic) & NDA development from lab scale to filing including support provided to external customer projects especially NDAs. The responsibilities included Pharmaceutical Development for USA, European Union & Canada , Assist regulatory department in filing of ANDAs and Assist in query response process by providing technical support.

KEY ACHIEVEMENTS :

  • Successfully developed complex generic products such as delayed / modified release products including several Para IVs forregulated markets viz. USA/Canada/EU in Lab & transferred technologies to scale/commercial scales.

Successfully reformulated key products to remove quality concerns and made them commercially viable.Successfully coordinated & completed DF development of NCEs for MNCs as part of CPS Group.

F. MOREPEN LABS, H.P.

Senior Group Leader Formulation Development July 2000 till Jun 2003

KEY ROLE & RESPONSIBILITIES :

  • Leading a team of Research scientists for Pharmaceutical Development for Regulated, Semiregulated markets & developed Rx & OTC products. My responsibilities included setting up of process development facility for ANDAs filings in USA, Assist regulatory department in filing of ANDAs, Assist in query response process by providing technical support. KEY ACHIEVEMENTS :Successfully developed and launched a food drink product in the OTC range which opend up huge opportunities and profits to the company.

G. Medicorp Technologies india Ltd., Manager R&D in Hyderabad

  • R&DJuly1999 to Jun 2000

KEY ROLE & RESPONSIBILITIES :

  • Headed the Product development Department and reported to Managing Director. Responsible for setting up their R&D facility, handling Product development, of products for EU markets.

H. J K PHARMACEUTICALS, Faridabad Group Leader

  • Product Development & ResearchMarch 1993 to Jun 2000

KEY ROLE & RESPONSIBILITIES :

  • Headed the Product development Department andreported to VP (R&D). Responsible for All technical inputs to project teams in setting up their R&D Centre, manufacturing facility, handling Product development, approval and commercialization of products for India & Export markets.

KEY ACHIEVEMENTS :

  • Setting of a new greenfield R&D & process development facility at plant leading to successful development of several products including Oral Solid/Liquids, Powder of Injectables & Semisolidsin Lab scale & technology transfer at commercial scales.
  • Successfully developed formulation recipes for over 100 products during 07 years of working for different dosage forms viz.Tablets, Capsules, Oral Suspensions,Topical creams, Dry powder & Liquid injectables

I. Ranbaxy Labs, Delhi , India Research Scientist in Product Development & Research department Jun 1990 Feb 1993

KEY ROLE & RESPONSIBILITIES :

  • Development of drug products for domestic (Indian) & semiregulated markets.

KEY ACHIEVEMENTS :

  • Undertaken Scaleup activities as part of Techtransfer of products developed in Lab scale.
  • Trouble shooting of existing commercial products at manufacturing location & also developed cost effective & environment friendly processes for several key products.

EDUCATION:

  • M. PHARM (Master in Pharmacy) : Hamdard College of Pharmacy, Delhi University 1990
  • B. PHARM. (Bachelor in Pharmacy): College of Pharmacy, Delhi University 1988

AWARDS & SCHOLARSHIPS:

  • Granted Scholarship after qualifying GATE exam conducted by IIT, Delhi for Junior Research Fellowship (M.Pharma) by University Grants Commission, Govt. of India.

PERSONAL DETAILS :

Date of Birth : 24th Dec, 1965

All other information shall be furnished upon request.

COMMUNICATION ADDRESS :

WZ 304, Street No.17, Shiv Nagar, Near Jail Road,New Delhi110058,

Landline 01125503251;