Contact Us

505-207-7740

GREEN CARD // CURRENTLY: Midwest – will relocate
Masters in Pharmacy – MS – Pharmaceutical Technology, Bachelor Degree in Pharmacy – BS // //
FORMULATION of Solid Orals (IR and ER Tablets and Capsules, Chewable Tablets and ODTs) // Liquid Orals (Solutions, Syrups, IR and ER Oral suspensions) É­ Dry syrups É­ Soft gelatin Capsule É­ // Parenteral formulations (Liquids and Solids) // ANDA / NDA (Para III /Para IV /First to File /505b2) and other international filings. // Formulation R&D Leader (Small molecules) and Subject Matter Expert, possessing 20 years of extensive experience in leading end-to-end product development viz. Pre-formulation, Formulation and Process development through QbD/DOE, Tech Transfers, Scale up, Regulatory Filings and up to drug product approval process in multi-disciplinary Organizations.

Certifications
4 days International Practical Training on Workshop of “Quality by Design (QbD)” by Dr. Shivang.
Qualified in competitive exams conducted at state and central level: EAMCET and GATE.
Awarded National Merit Scholarship for top rated performance in Academics.

WORK HISTORY

Nov 2015 to Apr 2016 and 02 May 2018 – Present

Senior Principal Scientist, R&D

Ensure timely execution and delivery of technical guidance to junior scientists for designing, reviewing, and evaluating potential development projects (Difficult to formulate / First to market) for filing ANDAs. Create detailed reports and submit final updates to VP, R&D, and technology transfer (India and US Teams).

Formulated, developed, and scaled up few oral liquid products, immediate release tablet containing seven strengths, and extended-release suspension for a combination drug product.
Credited with developing and completing the scale up batches manufacturing process.
Recognized for key contribution in guiding a development of a XR product and administering research and development.
Managed a CRO for analytical activities.

Nov 2015 to Apr 2016 and 02 May 2018 – Present

Senior Principal Scientist, R&D

Ensure timely execution and delivery of technical guidance to junior scientists for designing, reviewing, and evaluating potential development projects (Difficult to formulate / First to market) for filing ANDAs. Create detailed reports and submit final updates to VP, R&D, and technology transfer (India and US Teams).

Formulated, developed, and scaled up few oral liquid products, immediate release tablet containing seven strengths, and extended-release suspension for a combination drug product.
Credited with developing and completing the scale up batches manufacturing process.
Recognized for key contribution in guiding a development of a XR product and administering research and development.
Managed a CRO for analytical activities.

2014 – 2015

Senior Scientist II, FR&D

Developed complex generics under the supervision of Senior Director of FnD.

Credited with developing a combination drug product and filing of First to file application (ANDA) to FDA on time.
Developed a non-infringing complex generic product (Nano milling followed by Drug Coating onto the Career in Fluid Bed Processor by Top Spray, Blending, Compression and up to film Coating of a tablet).

2008 – 2014

Senior Scientist, PD (Managerial)

Guided and executed several new products developments through QbD, and filed over 10 ANDAs/ANDS. Supervised and developed pharmaceutical R&D studies. Solved technical and scientific issues for several filings to USFDA and Canada by addressing and authoring responses for the comments received from USFDA and Canadian regulatory agencies. Cultivated solid and productive rapport with FDA inspectors through preapproval inspection and received approvals for First-to-File products that launched into the US market on time. Created proto types for several other products, such as viz. Bi layer tablets, chewable tablets, extended-release suspension, immediate release suspension, and dry powder for reconstitution (Oral suspension). Prepared reports and forwarded final feedback to Associate Director, PD and VP, Product Development.

Added huge one-time revenues by stable annual revenues about $50M by successfully developing and registering over 10 ANDAs / ANDS for Oral solid dosage forms, IR and MR Tablets, and Capsules.
Nominated for Team Excellence Award in 2009 for the outstanding performance at Ohm Labs.
Attended PAI for a FTF product and added $300M revenue in the first year of launch.
Honored the excellence with company recognition ‘Regional and Global Team Excellence Awards in 2010’ for the outstanding performance and exceptional commitment for on time filing.

Research Scientist (2006 to 2008)

Successfully Developed, scaled up and Filed an ANDA (First to file application) for a Potent Compound (Category III) in less than a year. Attended the PAI that happened along with facility inspection and received the product approval. Company has gained huge profit through this FTF filing and approval.
Accomplished proto type development of two other products and made them ready for Scale up.

Manager (2003 to 2006)

Successfully developed and scaled up a dozen of non-infringing formulations for generic products, viz. Several Immediate Release and Controlled Release Tablet / Capsule formulations, two Liquid Injectables, one Lyophilized Injection, One Soft Gelatin Capsule formulation up to Commercial Scale, one Sachet containing Powder, one Liquid Suspension and Two Dry Powders for Oral suspension. All products were Successful in BE Studies.

Accomplished the Development, scale up and Filing of a non-infringing formulation for a low soluble compound for first time introduction in European market (First to Market). Owned a patent for the innovation, Patent

Pharmaceutical Composition for Acid Labile Substances (Benzimidazoles), Patent
Accomplished development of Fexofenadine Oral Suspension of (505 b2), Patent
Controlled Release Tablet formulation for Chrono therapy (A 505 b2/NDA).

Supervised and mentored several Scientists in FRD and managed other groups. Reported to Director, R&D at Lupin and GM, Project Management at TRC.

Scientist III (Group Leader) (1999 to 2003)

I am one of the two group leaders had worked aggressively, for initiating and expanding the R&D department for dosage form development including for regulated markets.

Supervised and developed the pharmaceutical R&D functions, including enhancing technical capabilities, and creating workflows. Successfully developed, scaled up and Filed more than 25 products (OSDs, and Injectables), majorly in Brazil and in other International Markets. Supervised and mentored several Junior Scientists to meet the targets assigned, and managed other groups. Reported to Board of Directors through Head, Regulatory.

Executive to Assistant Manager (1995 to 1999)

Successfully developed, Scaled and launched over 25 Liquid Orals and few Liquid Injectables in Indian market. Supervised Junior Scientists and Technicians in addition to directly working; Reported to General Manager, R&D.

FOR FULL RESUME CALL 505-207-7740