Amit patel

Responsible as New Product launch Team Lead for USA, Canada & EU markets. Leading Launch kick-off meeting to define strategy for sourcing, analytical, formulation, IP and regulatory for execution, monitoring, controlling day-to-day operations. Interfacing with R&D, Packaging development, MS&T, PTC, F&D, Quality, MFG, Procurement, Business Development, Logistic, etc to ensure proper operations engagement in all sourcing activities and launch execution on time. Directing overall technical scope, project costs & timelines, escalating potential challenges like capacity/resource constraints, reviewing projects and identifying early warning signals & on-time escalations.

• Responsible as Demand Planning Manager for Eastern Europe, Russia & Emerging Asian region Skus, Hold 1000+ Skus, Revenue around 426MN$. Executed APO DP/DRP/SAP. • Responsible for customer service enhancement, Ideal Inventory availability, Forecast Accuracy & Fidelity, reduction of sales loss, Optimize Sea mode shipment, Enabling new Launch Products, • Validating & finalizing consensus forecast with Market & do present to Demand planning Head. • Based on consensus forecast/orders do generate DRP output & do validation for production planning, also ensure stock build up due to AW/Site transfer/MA/GMP/Other variation issues. • Maintain Products inventory level as per Inventory norm and coordinate with Market for high inventory/Near Expiry SKUs liquidation plan, • Compute Forecast Accuracy (on M-1 FC), Forecast Fidelity (on M-2 FC) and discuss with country Manager. • Review pre-commits prepared by supply planners by assessing impact on Countries FG inventory level & opportunity sales loss. Prioritize the demand, wherever required. • Coordinate with PPIC, QA, QC, RA, Procurement, finance, IT, logistic team for day to day challenges to prioritize supply. • Maintain APO master, update inventory norms, hygiene of MTO Orders. • Review Sales history, Projection & Provide long range planning for finalizing work plan/Annual BDGT. • OTHER ROLE • Participated in SAP-APO implementation process in association with Accenture/Deloitte. • Demand-Commits Analysis for Terapia/Biosintez/International IH MFG Site/3P Skus with planning/Site Head. • Additional Handled demand planning activates for Emerging Asian Countries more than One Year, Hold 300+ Skus, Revenue around 86MN$. • Responsible to maintain MIS for EM & To Validate/support for data to be presented in Exe S&OP. • ACHIEVEMENTS • Earned Operational Excellent / Star Award from Sr VP, Initiated process for BF Code/FG Code Creation practice for Sun west Plant. • APO DP & DRP Go Live for EEU/Russia Skus,

Hold experience in UK and Romania green field operations. This includes budgeting, short-term and long-term planning, forecasting, new product launch, regulatory affairs activities, artworks management, orders management, batch release in EU, Sales trends analysis & competitive intelligence. Coordinating European customers among the top generic companies of the world.

To do correspondence with existing & new international clients, Merchant exporters concerning existing supply of goods, for new business development & their customary inquisition. Identifying and building new customer base, Generating inquiries & negotiating deals. Understanding about the documentation / regulatory requirement of various countries for APIs and formulations To negotiate and execute the agreements, preparation of quotations on the basis of response received & coordination of all activities of an enterprise in accordance with certain policies and in achievement of defined objectives. Planning & organizing for appropriate samples & documents for registration as per client’s country regulatory requirements & to follow up for the entire status of registration with clients. To guide & direct the team for day to day reporting & organizing routine used files. I have traveled Myanmar, Nigeria, Kenya, Thailand, Cambodia, Vietnam. Participated in East Asia countries’ Business Delegation & Buyer Seller meeting at Ahmedabad. Participated in Latin America Delegation & Buyer Seller meeting at Hyderabad. Participated in Middle East Asia countries’ Delegation & Buyer Seller meeting at Mumbai. Participated in CPHI, Nutra India Summit, Pharmaceutical Expo, Pharmexcil etc., exhibitions.

To accomplish production targets as well responsible for Upstream & DSP I process planning for production of bacterial culture products like PEG G – CSF, G – CSF, IL – 2, IFN, BMD. Doing Calibration of all Equipments and Instruments used for different batch processes like Fermenter, Cell disruptor, Shaker incubator; Centrifuge, Bulk freezer,– 80 °C Freezer; Filter integrity testing machine, Kill tank, etc. Processing & monitoring of VALIDATION batches & AUDIT batches. Update as well maintain records, logbooks, prepare validation batch report, BPCR, various technical documents, trend analysis as well other QA related documents. Equipment qualification: Preparation of qualification documents (URS, DQ, IQ, OQ, PQ & PV) on time in and carry out qualification of equipment / instruments before qualification due date. Successfully carry out validation or production batches in front of various auditors/during various audits e.g. EU, Brumidine, Brazil, etc.