Posted by on January 01, 19101 at 23:39:21:
DHARMESH KHARWAR
25, Warden Court, A K. Street, Mumbai 400036, India
Home: +91-22- 380-6348/380-4834
Email: dkharwar@yahoo.com
OBJECTIVE: Seeking a challenging position in pharmaceutical formulation development and technical services.
SUMMARY OF
EXPERIENCE: Broad experience of more than 5 years, working in formulation development, process validation and technical service roles. Overachieved goals in product reformulation / repackaging for shelf-life extension for climatic zone IV. Recognized for unique ability in delivering creative solutions for complex situations. Working on laboratory, pilot and production scales encompassing the entire project life cycle starting from conceptual phase to launch phase.
· A hands-on professional with a proven record of success.
· Able to handle multiple projects concurrently.
· Articulate and creative, offering innovative and practical solutions.
· Able to work with others towards a team goal.
· Recognized Regulatory/ Marketing / QA / Production needs, and met them.
EXPERIENCE: Executive – Technical Services
Sept. 98 to Present Fortune 500 American healthcare multinational with sales US$ 27.5 bn.
Current location: Mumbai, India.
· Specialization: Formulation design/implementation, stability monitoring, process validation, trouble shooting.
· Major Projects
Formulated uncoated & film-coated tablets including 0.25 & 0.5 mg strengths of an anti-psychotic drug.
Developed line extensions of an anti-dandruff shampoo range.
Made oral solution using HPβCD for better bioavailibility.
Reformulated liquid oral products & tablets to meet changed regulatory requirements.
Improved formulation/ packaging of various tablet products to improve the shelf life.
Demonstrated stability of products in alternative primary /secondary packing to contain costs.
Implemented two projects of high-shear mixer / fluid bed dryer / blender / compression
For processing batch size ranging from 40 kg to 400 kg of tablet products.
Equipment IQ/ OQ/PQ support.
Laboratory / pilot scale batches manufacturing.
Full process validation on scale-up batches.
· IQ/ OQ/PQ of automated film-coating equipment.
· Evaluated new processing technology to increase overall productivity of the company.
· Responsible for the regulatory aspects relating to the formulations.
· Core member of the New Product Development Team attended by top level executives.
· Quality Tools namely 3-6-10 Process parameters, 6 Sigma measurements, Cycle time measurements at
Laboratory level (Regulatory, QA, QC).
· Currently gaining hands-on experience on Waters/ Millenium HPLC system.
July 94 to Executive – R & D: Formulation
Aug. 98 FDC Limited, Mumbai, India.
· Hands-on experience of handling projects of formulating
Tablets: Uncoated, film-coated, enteric coated, chewable, dispersible, effervescent, controlled release.
Capsules: Hard gelatin, powder blend filled, bead/ spherule filled.
Injectables: vial and ampoule primary pack
Ophthalmics: Clear liquids and suspensions in vial and FFS (unit & multidose) technologies.
Topicals: Dusting powders, creams, gels, ointments
Liquid orals: Clear liquids, suspensions, and long acting, antibiotic dry syrups.
Oral rehydration salts: Compositions for reconstitution, effervescent tablets/ granules, ready-to-drink.
· Experience of handling various API’s including anti-biotics, anti-bacterials, anti-fungals, CNS active agents, analgesics, anti-inflammatory,
· Improved upon the first prefilled syringe system for intraocular injections introduced in India.
· Conversant with the lyophillization and extrusion-spheronization technologies.
EDUCATION: M.S. (Master of Pharmacy – Pharmaceutics)
Department of Pharmaceutical Sciences, Nagpur Univ. India. Date of Graduation: July 1994
Coursework: Product development and formulation, Advanced physical pharmacy, Biopharmaceutics &
Pharmacokinetics, Biostatistics, Pharmaceutical dosage form technology and projects.
Project: Developed a film-forming gel formulation containing a natural biopolymer as a carrier for topical drugs.
B.S. (Bachelor of Pharmacy)
NCP, Nagpur Univ. India Date of Graduation: June, 1992
TRAINING:
Statistical Tools :Design Of Experiments, Statistical Process Control, Failure Mode Effect Analysis
Film -CoatingColorcon International, Rohm
Flavors and FragrancesBush Boake Allen
Tablet Compression TechnologyKorsch
Self-Emulsifying-Drug Delivery SystemsGattefosse
Direct Compression IngredientsDM, Meggle
CyclodextrinsCerestar
Stability GuidelinesUS FDA Draft, ICH & WHO by Dr. Saranjit Singh, NIPER
MERITS: Chapter on validation published in the official ‘QA Guide’ of the apex pharmaceutical industry body of multinationals in India.
BOOK REVIEW: On the panel of experts of Indian Pharmaceutical Association.
ACCREDITATIONS: Registered Pharmacist, Maharashtra State, India.
PROFESSIONAL MEMBERSHIPS: Indian Pharmaceutical Association.
COMPUTER / IT: High level of use for daily operations.
PRESENTATIONS: Made for corporate and non-corporate audience.
ACTIVITIES: Active member of the “Indian Pharmaceutical Association.”
Helped organize various activities including seminars, conferences, and medical checkup camps.
Participation in the “Indian Pharmaceutical Congress.”
This is the only comprehensive conference of its kind in India where industry, academia, equipment manufacturers, raw material vendors and the ancillary interact for four days.
Self Development
Completed the “Landmark Forum”
It helped me to improve personal relationships, made me a more effective person and think productively about my life and goals.
In close touch with “Neuro Linguistic Programming.” practicing professionals
This helps me to constantly improve my skills in all areas of my life.
Avid involvement with “Lateral Thinking and creativity”
It enables me think of new methods for routine and squeeze jobs.
PERSONAL: Indian Citizen
References Available Upon Request.
Passport ready.
WILLING TO IMMIGRATE TO ANY LOCATION IMMEDIATELY.