Product Development Manager

Niravkumar Patel

614-***-**** **** Gateway Lakes Drive, Grove City, OH 43123 **********@*****.*** EDUCATION

Master of Pharmaceutical Science (Pharmaceutics) 8/2012 – 5/2014 Gujarat Technological University, India

Bachelor of Pharmaceutical Science 9/2007 – 9/2011 Rajiv Gandhi University of Health Science, India

CERTIFICATE/LICENSE

Licensed Pharmacist from Gujarat, Indian Pharmacy Council EXPERIENCE

Quality Control Chemist KDC Tritech Laboratories 6/2017 – Current

Perform various qualitative and quantitative laboratory tests for raw materials, in-process bulk and finished bulk products

Assist QC manager with investigation of Out of Specification (OOS) results and writing reports using trackwise system

Analyze bulk product testing results, offer recommended adjustments to compounding and corrective measures to the QC management team if needed

Responsible for writing and editing scientific reports, SOPs and providing input on study design and execution

Facilitate the assemble and calibration of scientific testing and laboratory instruments

Assist R&D team for lab batch formulation and implementing DOE for product development and optimization

Prepare Certificate of Analysis for product test results and complete product releases in company data processing system (SAP) Formulation Scientist Helios Pharmaceuticals Pvt. Ltd. 5/2014 – 4/2016

Planned and prepared pilot scale batches to develop and optimize conventional and sustained release solid oral and topical semi solid dosage forms

Implemented Qbd for product development

Executed trials for prototype formulation development and optimization (Employing DoE Approach)

Profiled physico-chemical characterization of API and Excipients

Conducted API, Excipients and formulation stability studies

Performed analytical method development and validation associated with generic development

Presided as a technical assistant within the company for product development, scale-up and post approval changes

Characterized batches to identify formulation/process variables affecting product critical quality attributes

Carried literature survey and analysis of patents for troubleshooting and formulation development

Provided formulation assessments during product complaint investigations

Executed troubleshooting work in support of the manufacturing operations

Organized lab setting and schedule to provide project status, reports and results in timely manner

Documentation:

o Generation of Scale-Up records, preparation of master batch manufacturing Record (BMR), Product development report

(PDR), cGMP and cGLP lab notebook documentation, Writing protocols for Scale-Up, process validation and preparation of reports for submittal to regulatory affairs for filling. ACCOMPLISHMENTS

Developed NDDS for treatment of dental pain and type 2 diabetes

“Formulation and evaluation of periodontal film dosage form containing Lornoxicam”

“Formulation and Characterization of Gastro Retentive Tablets of Acarbose” TECHNICAL SKILLS

Product Development: Progressive experience in CDMO with development of topical, solid oral and extended release dosage forms Knowledge of USP, NF, cGMP, cGLP, SOPs and ICH guidelines

Analytical: Familiar with UV Visible Spectroscopy, GC-FID, FTIR, Karl Fischer, Dissolution Apparatus, TLC, Moisture Balances, Volumetric and gravimetric analysis as well as knowledge of HPLC-UV, TGA, XRD, DSC

Manufacturing: Familiar with various techniques and equipment of blending, granulation, fluid bed drying, compression, coating, planetary mixer, colloidal mill and other equipment used for manufacturing of tablets and semi solids

Proven ability to develop and manage multiple research programs with strong technical background in analytical development, Manufacturing and scale-up

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