Sameer Bhide Email & Phone Number

Udaipur, Rajasthan, India

 Leading a team of Researchers for the Analysis of Synthesised Target Molecules for the Discovery and Process Research Group. Serving as an Active Member of Research Development Management Committee for strategic decision-making Spearheading Pre-development of Innovative Chemicals for Crop Protection / Crop Growth, adding value to the business Working in the domain of Agro Kinetics including the determination of physical-chemical properties, for best results  Directing all Strategic, Operational, Financial - Initiatives and Budgets, for streamlined operations and cost-efficiency  Liaising with R&D Dept. for new processes/products/ process improvements, scale-up optimization, and technology transfer of the product Facilitating Transfer and Validation of Analytical Methods, review and approval of method transfer and method validation pre-approval protocol, as per defined procedures  Playing a key role in identification, discussion, and negotiation with CMOs/CROs, aligning CMO/CRO Team to Internal Teams, feasibility/development trials, suitability of Technology Transfer, and finalization of the process for smooth Transfer  Organizing activities for alternate method development, smooth execution of validation batches at pilot and manufacturing scale Facilitating the preparation and review of MIS Reports/ Dashboards/ KPIs for crucial decision-making  Maintaining smooth operations, housekeeping and adherence to HSE standards in the plant for a safe & clean environment, ensuring maximum safety, zero accidents /incidents at sites Providing leadership to a multi-skilled workforce, ensuring a harmonious work environment through Employee Engagement/ Motivation/ Training  Setting up a Centre of Excellence for Solid State Analysis catering to Discovery Research and CDMO business

Bengaluru Area, India

 Led all Stability Programs for Multiple Product Lines including initiation, scheduling, inventory, testing, data review, trending, and data archiving activities Assured accurate, submission-ready Stability Data information compliant with Health Authority Guidelines Provided qualitative inputs on the pricing of large complex proposals, served as a first point of contact for clients Established Stability as a Business Unit at Syngene for providing Stability Services to Early Phase, Late Phase, Registration, and Commercial Stability as a Site Head Achieved revenue growth for the newly set BU @ rate of 10-15% per year from 2016 - 2021 Led the design and implementation of Phase Appropriate Quality (PAQs) systems for the first time at Syngene Worked as Early Phase GMP Lead, for Analytical Development Dept. catering to Stability Samples, and managed Analytical Support, Planning to Manufacturing of Technical Batches, Validation, Release Testing and Stability Studies Responsible for P&L of the Business Unit, achieved Monthly Targets and Yearly PAT for the Stability Center through judicious use of manpower, controlling recruitment and capex expenditure. Oversaw Reports/ KPI Preparation  Served as a Key Point of Contact for all QC -related Analytical Activities performed at External Partners under GMP with a focus on Method Transfer and Stability Testing for both Clinical/ Commercial Materials and Manufacturing Support Played a key role in Audits and Inspections. Drafted, finalized and approved Quality Agreements with clients for clauses related to Analytical Dept. Worked with Dupont to implement stringent Safety Measures across the site, ensuring maximum safety  Ensured timely delivery of Technical Programs/Projects. Collaborated with the Leadership and Sr. Management Team in strategic planning, budgeting, and new capabilities development Won Client Appreciations and Task Master Award for Advancing the Molecule in 2020

Mumbai

 Spearheaded all Operations and Site-related Administration Activities as a Site Head Managed Cross-Functional Departments like Analytical Method Development, Validation, Quality Control, QA, Stability, and Microbiology; provided support to increase the business and meet customer requirements Collaborated with the Site QA and Global QA to harmonize and establish Global Compliance Systems, for strengthening quality awareness and supporting analytical operations Transferred Analytical Methods to the QC Department at Production Sites. Prepared monthly KPI Report, owned P&L of, and maintained finances below budgeted expenses Led & guided a group of 60+ Associates to ensure cGMP Practices in QC and Analytical Method Development  Handled Customer Audits and ensured that all aspects of Pharmaceutical Analysis complied with Client’s, Company’s and Global Regulatory Requirements Reviewed Quality Agreements with clients and ensured that activities were done timely & as per defined agreement Administered timely Calibration/ AMCs /Maintenance, and Troubleshooting of Utilities & Analytical Instruments (UV, HPLC and Dissolution Tester) Analysed Initial and Stability Batches of Finished Products such as Tablets (IR, SR, and Delayed Release Tablets), Capsules Dry Syrups, Liquid Orals, Injections, Creams, and Ointments as per ICH Norms Pivotal in setting up the Site and Systems as per GxP requirements and making the site ready for Outsourced Work Drove Client Collaboration by establishing an Insourcing Model on the client site (Top MNC Pharma Co.)

Mumbai Area, India

Handling a team of scientists and dealing with Projects for Stability studies, Method Development, Method Validation. Liasing with stakeholders and ensuring project delivery within timelines

Mumbai

Worked as Team Lead ( handling group of 8-10 people)and handled various projects for Stability Studies, Method Validation, Method Development

Mumbai

Worked in CPD department leading a group of 7-8 people, handling stability, Validations and Development.

Mumbai

Worked in API R&D , JOb profile involved Method Development, Validations,Method transfer to various locations. Supporting queries for Regualtory Department

Ph.D, Chemistry

University Department of Chemical Technology, Matunga, Mumbai University, India Topic of Research: Studies in Surface Chemistry 2002

H.Sc., B.Sc. M.Sc, Organic Chemistry

Ssc, Chemisrty