Viral Shah Email & Phone Number

Bentonville, Arkansas, Us

Bentonville, Arkansas, Us

• Design strategic product/business development plans and manage P&L for private brand. • Manage the development of Private Brand products with other business areas (Brand Marketing, Merchandising, Regulatory, compliance, Legal) and develop Business opportunities for the Private Brand portfolio.• While managing existing business, analyse market trends and build deep dive for new product/brand opportunities/merchandising• Manage product lifecycle from ideation through commercialization.• Write detail product specification for new item bid includes formulation, packaging, label etc.• Identify CPG partner / supplier, co-develop product with R&D, organoleptic team, negotiate cost and commercialize.• Develop exclusive new brands and pricing strategy.• Audit supplier’s manufacturing, packaging facility and Quality management system etc.• Influence team members including replenishment, sourcing, legal, patent, social compliance, and product compliance.• Partner with different country teams to launch products.• Work with Global sourcing team for new item development and COGS initiative • Work closely with sustainability team for packaging / product development Manage In stock, inventory planning, vendor operational improvement (efficiency, fill rates, lead time), forecasting, and shrink reduction• Partner with internal teams for process improvements that affect CPG supplier selection, product development, and quality improvement and vendor management.• Provide technical support to the Private Brand team by developing and maintaining relationships with other internal and external resources (Sourcing, Legal, Compliance departments, Regulatory) facilitating approval process with patent, regulatory and legal.

Stuart, Fl, Us

• Formulated/ Developed NDA and ANDA drug products• Prepared ANDA, NDA documents for FDA filings• Planned project related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.• Prepared and presented technical presentations/reports on experimental outcomes.• Developed manufacturing processes for registration and commercial batches.• Consult and interact closely with other departments to define the formulation and manufacturing processes within the constraints of clinical, legal, analytical, regulatory and production requirements.• Experience working with controlled substances formulation and required DEA documentation. • Managed and performed raw material sourcing for Formulation Development Efforts.

Bridgewater, New Jersey, Us

• Led and managed all Analytical Development, Qualifications, Validations of active pharmaceutical ingredients, excipients and dosage forms testing and release activities, in process analytical testing in support of formulation development.• Prepared reports for ANDA submission.• Performed Reverse engineering of brand product for generic drug development• Developed methods and protocol for analytical testing of formulations

Bridgewater, New Jersey, Us

• Reverse Engineering: Evaluate physico-chemical Characteristics of oral solid dosage forms and perform Drug-Excipient compatibility studies.• Actively participated in Dissolution (Apparatus I, II, III, IV) and early phase Formulation Development • Performed several analytical testing include: Testing parameters for tablets, capsules including hardness testing, friability testing, disintegration, rupture and dissolution studies• Created technical reports, prepared graphs and charts to document experimental results.• Performed chemical experiments by using techniques such as chromatography, spectroscopy, (HPLC, UPLC, DSC, TGA, FT-IR, Dissolution and KF )• Provided technical support and assistance to chemists and research leaders.• Developed sampling programs and conducted analysis to maintain quality standards of raw materials, chemical intermediates, and products.• Performed Pre-Formulation, Stability and Solubility Studies.

• Developed Personal care and Beauty formulations eg. Hair gel, Shower gel, Skin ointment -powder, CCF Syrups• Assist Formulation Scientist in Preparation of pharmaceutical formulations• Maintained and updated BMR & BPR • Actively interacted with Process Validation Team• SOP review and update

• Managed development of bulk drug production in tablet and capsule manufacturing area.• Assist Formulation Scientist and worked on pharmaceutical equipment - milling, blending, dry granulation, wet granulation, fluid-bed granulation, tablet compression, and coating in preparation of formulations• Administered quality control and quality assurance methods• Documented relevant information regarding released product

Ms, Pharmaceutical Science (Industrial Pharmacy)

B.Pharm, Pharmacy