Sumel Singh Email & Phone Number

Toronto, Ontario, Canada

As a dedicated product manager, I bring a strategic, data-driven approach to developing impactful products that align with business goals and meet market needs. My expertise includes leveraging insights into cleaning validation principles and process validation to inform decision-making and deliver high-quality solutions. I specialize in defining a clear product vision, creating roadmaps, and collaborating with cross-functional teams to develop solutions that resonate with users.I lead with a customer-centric focus, identifying gaps and unmet needs to guide product development. By collaborating with UX researchers and incorporating competitive insights, I ensure our offerings are innovative and relevant. I’m committed to operational excellence, establishing metrics like MRR, CLTV, CAC, and NPS to track success, optimize processes, and measure progress.I also build high-performing teams, foster a user-focused culture, and encourage continuous learning and performance improvement. Engaging directly with customers, I gather feedback to refine products and support sales teams in strengthening relationships with key stakeholders. I actively represent the product at industry events, driving engagement and maintaining a competitive edge.Through a blend of strategic foresight, team leadership, and a passion for continuous improvement, I create value-driven products that exceed expectations and drive growth.

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

Developing a SaaS based paperless environment across the healthcare industry to improve data integrity and automation- Managing validation protocols, batch records, cleaning validation, analytical method validations, electronic logbooks in the GxP environment-Understand, execute and modify controlled documents in the GxP environment-Development of a life cycle management of all the GxP documents in the electronic document management system

Toronto, Ontario, Canada

· Effectively process batches within specifications as per SOD’s, GDP, and GMP requirements, i.e., observations, test results, batch record information, etc. · Dismantle, clean, sanitize, and assemble manufacturing equipment according to established SODs to ensure GMP compliance· Execute applicable SAP and LIMS transactions accurately and in a timely manner· Complete master batch records and associated production documentation accurately and timely· Issue maintenance notifications and prepare equipment for maintenance work orders as required

Mississauga, Ontario, Canada

· Packaging products into various formats to meet GMP, Standard Operating Procedures (SOP) requirements and Government Standards in regards to safety and quality of the products.· On line inspections of packaging material and product exercising documentation practices, to ensure quality standards are being met and informing Packaging Supervisor when quality issues arise.· Working in compliance with established GMP and safe work practices and procedures, using required clothing, personal protection and safety equipment as required.· Supporting team goals on assigned packaging lines to meet daily schedules, optimize change over times and ensure on time delivery to customers.· Assisting in the development and implementation of Continuous Improvement initiatives to improve quality and efficiencies in packaging department.· Transfer materials and finished goods between various work areas.

Gurgaon, India

· SmartAnalyst (a subsidiary of UDG Healthcare) combines in-depth knowledge of the evolving therapeutic paradigms and commercialization models for actionable recommendations to drive pipeline and portfolio value· New Product and In-Market Forecasting: Using Evaluate Pharma (EP) database, ProQuest, Cowen, etc. to fetch data from analyst reports and other publications to analyze sales and forecast for project requirements like corporate strategy, portfolio management, manufacturing, marketing, sales, etc.· Systematic Literature Reviews (SLRs) summarize existing research for a clearly-defined goal using OVID SP, Cochrane, PubMed, Medline, Embase, etc. to perform Meta-Analysis for outcome comparisons

Gurgaon, Haryana, India

· BD&L (Business development & In-licensing): Filling portfolio gaps through BD&L: Screening, prioritization, and in-depth commercial assessment and independent valuation of opportunities in Oncology and Non-Oncology areas Asset label and pre-positioning and messaging: simulating the label as value driver; developing asset positioning messages Asset Value Proposition: Clinical and Payor benefit thresholds and evidence required for success; help drive asset go/no-go decision and value proposition Commercial assessment to understand forecast drivers· Portfolio Strategy: Portfolio tradeoffs and optimization: Program correlations and risk-return tradeoffs to optimize portfolio value· Disease Strategy: Discovery and commercial alignment: strategic framework and tool to determine what early programs to pursue and gain alignment between discovery and commercial· Identification of Key Opinion Leaders (KOL) and designing discussion guides· Global\Region specific Health Technology Assessments (HTA’s)

Hyderabad Area, India

· Working on professional instruments like HPLC, UPLC Systems, LCMS Systems, UV Spectro-photometer, XRD and many more used in analytical division· Maintaining the highest level of GMP and practice CAPA in all R&D operations and adhere to all the quality parameters and procedures as per the stringent norms· Maintenance of HPLC Columns, Working, Reference Standards, Data Integrity, and GLP· Method Validation and Development for a drug product (Injections and Solid orals) which include analysis through Residual Substance (RS), different types of Assay, Dissolution, etc.· Accomplishing tasks for queries from regulatory authorities for drug filling in US, EU, Japan and ROW· Providing training to new trainees, maintaining training records and reviewing completeness· Creating and reviewing R&D documents according to established priorities and standards· Maintaining logbooks, procedural and review documents for smooth regulatory filings· Working closely with the regulatory department for understanding need to get smooth fillings· Preparing and reviewing of analytical method development and validation reports and COA’s, Calibration of Instruments· Inspecting, self-testing, sampling, troubleshooting and solving analytical related problems using LIMS

Analytical Department, R&D Centre

Hyderabad Area, India

· Completing academic requirement and submitting a thesis on “Development and Validation of Stability Indicating Method for Assay of Moxifloxacin Hydrochloride Solid Oral Tablets by RP-HPLC”