K.VISWANATH, M. Pharm.

“Research Scientist – Global Generic Product Development

for Parenteral and OSD”.

Mobile: +918008204672 e-mail: viswa.kaly@gmail.com

OBJECTIVE:
 To acquire a position to utilize my skills and abilities in the industry and to seek every opportunity
that offers professional growth, while being creative, resourceful and flexible.
 Creative in identifying and designing effective solution to meet the current and future expectations
of pharmaceutical Technology.
PROFESSIONAL PROFILE: (9 & ½ years + experienced in pharma industry across diverse domains)
5years+ experience in R&D after M. Pharm
 Research Scientist – I (Group leader) – Pfizer (Parenteral dosage form) – Feb 2016 to till date
 Scientist Formulation Research and Development (Assistant Manager) - Dr.Reddy’s laboratories –
May-2010 to Jan 2016 (5 years & 9 months)
 2 years & 8 months experience in production and QA after B. Pharm
Banner pharmacaps (Geltec) – Chemist production - Dec 2005 to Apr 2007
Himalaya –Executive Production (Corporate QA) – May 2007 to Nov 2007
Shasun Pharmaceuticals – Officer Production – Dec 2007 to Jul 2008
JOB RESPONSIBILITIES HANDLED:
 Development of solid oral and injectable formulations for generic market.
 Scale up of developed solid oral and injectable formulations for generic market.
 Technical presentation on project progressing to cross functional team members at different stages
of project.
 Active participation in strategy discussion for new product and process development along
with strategy development team and other cross functional team member.
 Preformulation studies of the product under development.
 Stability data generation for API and prototype formulation.
 Execution of all developmental trials which were involved in the prototype formulation
development.
 Reviewing of analytical data for each trial batch executed.
 Dissolution mapping of the working formula with innovator in OGD and bio relevant media.
 Execution of pilot bio batches, process optimization batches, and scale
up/confirmatory/Engineering batches.
 Execution of exhibit batches at USFDA and MHRA approved pilot plants situated at
different geographies.
  Data review and analysis of BE study.
 Coordination with cross functional teams for successful filing of dossier and launch of the
product in different geographies.
 Documentation responsibilities
Pre exhibit documentation
 Preparation of sampling protocol / Process verification protocol, Hold study protocol, stability data
compilation report and process optimization report.
Post exhibit documentation
 Preparation of Manufacturing formula record, Manufacturing instructions (MPR) PASIX MBR
review and PORM for commercial batches and exhibit batch summary report / process verification
report.
MILE STONES IN PROFESSIONAL CARRIER:
 Received Certificate of completion for completion Filtration School 117 conducted by Merck
(Millipore).
 Received Certificate of excellence for completion of QbD workshop by SSA Business solutions
an authorized IACET provider
 Received Certificate of completion for completion of Lyo school by Pfizer
 Received “Best Poster award”, on OSD science day 2014 at Dr. Reddy’s for the poster - An
illustration of, “Swift in product development with collaboration to touch the lives in time is
the need of the hour”
 Received “Best complex product development and delivery (2014)”, award from Dr.Reddy’s for
development of a product containing blood thinner
 Developed an oncology solid oral dosage form and had exposure to work in potent molecules
processing plant
 Had exposure with Quality by Design (QBD) based product development
 Had exposure in handling Design of Experiments (DoE) and its software Design expert 8.0.
 Completed basic fire fighting safety training and certified as “Life saver”, by USHA fire safety
equipments pvt. Ltd
 Received “Best value creation through functional excellence – Process & Eng.(Formulation)”
on Jan 11 from Dr.Reddy’s
 Establishment of pilot plant at Baddi location for Dr.Reddy’s.
 Recognized as a certified trainer by Dr.Reddy’s FTO 6 Baddi
 Appreciated by BANNER PHARMACAPS for monitoring and guiding the operator to
manufacture/run a prestigious product called VOVERANPLUS in soflet setting on Shoc
encapsulation machine at higher speed of 5.0 RPM which is a very hard one to achieve.
 Good knowledge in soft gelatin capsule and soflet manufacturing. Shoc and Chase encapsulation
machine trained.
AUDITS FACED SUCCESSFULLY:
USFDA, MHRA, TGA, MINISTRY OF HEALTH JORDON, MAYNAE, PHARMACARE, GSK,
NOVARTIS, RANBAXY, DRL, ABBORT, BOOTS INTERNATIONAL, ELDER.
PROJECTS WORKED:

1. Product development of Injectable dosage form for a molecule indicated for preterm birth which is
highly potent, hormonal and oncolytic – Oily liquid injection with Aseptic filtration for sterilization.
2. Product development of Injectable dosage form for a oncolytic molecule – Lyophilization product
3. Product development of Injectable dosage form for a Pharmacological stress producing agent which
is highly potent – Aqueous liquid injection with Terminal sterilization.
4. Product development of anti-coagulant molecule used for stroke- 3 strengths viz., 150mg,110mg
and 75mg – Fluid bed granulation (pellets) – Bottom spray process.
5. Product development of Anti cancer molecule for US and EU market - posses 3 strengths, viz.,
400mg, 100mg & 50mg – Roller compaction process.
6. Product development of anti-arrhythmic molecule – 400 mg strength- two strategies for dissolution
enhancement – Wet granulation process.
7. Product development of bile acid sequestering molecule – 625mg strength – Wet granulation &
Roller compaction process.
8. Product development of BCS class IV antihypertensive molecule – 2mg and 4mg strength – Solid
dispersion – Wet granulation process.
9. Product development of Antiepileptic molecule – 10mg and 20mg strength – Wet granulation
process.
10. Process development of (IR) solid oral dosage forms of Anti-hypertensive molecule for US and EU
market- 3 strengths, viz., 75mg, 150mg, 300mg respectively –Fluid bed granulation process - Top
spray process & Roller compaction process.
11. Process development of a (IR) solid oral dosage form which has the combination of Angiotensin II
receptor antagonist with a Diuretic for US and Europe market – 5strengts Viz., 320/25mg,
320/12.5mg, 160/25mg, 160/12.5mg and 80/12.5mg – Roller compaction process.
12. Process development of (IR) solid oral dosage form of a proton pump inhibitor molecule, (the same
formulation also had NaHCO3 in it) for US market – 2 strengths and one OTC
formulation,viz.,20mg/1.2g,40mg/1.2g and 20mg/1.2g (OTC) – Direct blending, capsule filling, &
banding process.
13. Process development of (IR) solid oral dosage forms of Anti-hypertensive molecule for US and EU
market- 3 strengths, viz., 20mg, 40mg, 80mg respectively –Fluid bed process - Top spray process
14. Formulation and in vitro evaluation of Itopride hydrochloride hydrodynamically balanced drug
delivery system – Post graduation.
 15. Pharmacognostical, Preliminary Phytochemical, Hepatoprotective studies on Leaves of Tylophora
indica- Under graduation
PERSONAL SKILLS:
 Comprehensive problem solving abilities, Ability to deal with people willingness to learn, self-
motivation, Team facilitator.
AREA OF INTEREST:
 Global Product Development.
ACADEMIC QUALIFICATION:
S.No Course College / University Duration Class
M. Pharm
Vels College of pharmacy /
(Phar First
1 The Tamilnadu Dr.M.G.R Medical 2008-2010
maceu class
University
tics)
Adhiparasakthi College of Pharmacy /
First
2 B. Pharm The Tamilnadu Dr.M.G.R Medical 2001-2005
class
University

PERSONAL PROFILE:
Date of birth : 07.02.1984
Sex : Male
Marital status : Married
Linguistic Proficiency : Tamil, English, Kannada, Telugu and Hindi.
Present Address : Sri Bhavitha Homes, Krishna Flats,
Flat No.S1 Second Floor,
Plot No. 67, 5th Street Jeeva Nagar
Mangadu, Chennai - 600122
Permanent Address : No.115/B N.G.G.O Colony, Salamedu,
Villupuram-605401
DECLARATION
I hereby declare that all the details given above are true to the best of my knowledge and belief.
Place: Hyderabad.
Date:
Best,

( V I S WA N AT H . K )