Manufacturing Development

Professional summary

Experienced scientist in a pharmaceutical setting in formulation

development of - Parenterals, Solid orals and Liquid oral formulations,

with several 1st in India & World commercialization's.

Knowledge and experience in manufacturing of solid orals and injectable

formulations.

Professional Experience

Scientist II, Formulation Development,

2008 - 2013

Torrent Research Center, Gandhinagar, India.

Key Result Areas

QbD based design, development and optimization of formulations and

processes (ANDA and National market),

Design, monitor and execute experiments leading to cost and time efficient,

robust, non-infringing, rational and scientifically sound, formulations

and manufacturing processes; often handling multiple projects concurrently

Interpret and evaluate results data, draw relevant conclusions; ensure

compliance with product quality, performance and efficiency, also

demonstrate cost consciousness in all assigned projects.

Formulation and process optimization, together with preformulation and

stability studies, scale up and technology transfer of all aspects of

Injectable - liquid and lyophilized, solid orals - tablets and capsules and

liquid orals - syrups and suspensions dosage forms,

Generate, review and present documentation; lab notebooks, regulatory

submissions, master formula and manufacturing procedures, product

development reports, protocols, technical reviews,

Contribute to risk analyses, review and process challenge/strategy

meetings,

Interface with other functions to facilitate transfer of knowledge and on

time deliveries of drug products,

Working knowledge of R&D and large scale equipments; granulators, tablet

presses, capsule filling machines, lyophilizer, autoclaves, liquid

orals and injections filling and sealing machines.

Production Chemist, 2005 -

2006

Alkem Laboratories Ltd., Daman, India.

Key Result Areas

Supervising manufacturing of Tablets and Capsules, also Dry and Liquid

injection manufacturing and packaging with respect to timelines, process

parameters and product specifications,

Handling of equipments of tablet, capsule and injection departments,

Receive BMR and Raw materials, updation of BMR, cleaning, maintenance and

calibration logs, ensuring compliance to cGMP

Manpower and work allocation, Training towards cGMP and documentation

procedures.

SOP review and preparation, Validation and Qualification activities.

Education

PhD Student, Pharmaceutical Sciences, 2010 - Expected graduation - 2014

Kadi Sarva Vishwavidyalaya. Gandhinagar, India

Master of Pharmacy, Pharmaceutics, 2008

S.K.B college of Pharmacy, RTM Nagpur University, Nagpur, India

Bachelor of Pharmacy, 2003

S.J.M college of Pharmacy, Rajiv Gandhi University of Health Sciences,

Bengaluru, India

Publications

Eudragit-S, Eudragit-L and cellulose acetate phthalate coated

polysaccharide tablets for colonic targeted delivery of azathioprine.

[Pharm Dev Technol. 2010 Jul-Aug;15(4):431-7.]

Carbopol-934 - Sodium Alginate - Gelatin Mucoadhesive Tablets for

Ondansetron Buccal Delivery: Effect of pH Modifiers. [Indian J Pharm Sci.

2010 Jul-Aug; 72(4): 471-479.]

Presentations

Oat gum - An assessment of its binding properties. [CRS Indian Chapter,

Ahmedabad, 2008.]

Microbiological characterization and evaluation of an ayurvedic cough

syrup. [Avishkar 2007-08 (Science Fest), RTM Nagpur University, IPER,

Wardha.]

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