Manuel O. Email and Phone Number

Software Product Manager: Bioinformatics Tool for Target Enrichment Custom Panel Design• Business owner of a Target Enrichment cloud solution with over 500 new users per year across 45 countries.• Accomplished 50% conversion rate of panels completed by customers to purchase orders and business growth of 20% YoY during the first 4 years after launch.• Defined the product roadmap of software features based on portfolio launches, customer feedback, and software throughput KPIs.• Explained bioinformatics requirements and concepts to software developers.• Coordinated software product support for customers and internal users.• Conducted business reviews and monitored budget and capacity of software development resources.Reagents Product Manager: Target Enrichment Sample Prep for Next Generation Sequencing • Positioned a product line of a new Target Enrichment technology based on Primer Extension.• Defined the market development strategy and activities, and established the process for prioritizing high-value customers to drive technology adoption and business growth.• Drafted product evaluation agreements to capture key accounts and generate marketing collateral of product performance on specific use cases.• Managed specialized service and reagent workflow support for high-value customers and accounts.• Established the B2B commercial processes and conducted business reviews to forecast reagent demand and production.• Planned the product improvements roadmap based on customer requirements and sales affiliate input and feedback.

• Supported the commercial launch of a new line of reagent products based on Primer Extension Target Enrichment.• Developed and implemented business analytics and reports to monitor and improve successful software usage and performance.

• Analyze business and operational data from biomedical diagnostic products and their numerical parameters to create tools that facilitate sales operations and enable increasing revenue. • Collaborate closely with International Product Managers for various biomedical product brands to understand end-user requirements, coordinate and oversee product orders and priorities, and compile summary reports and real-time order fulfillment status accounts to affiliates. • Generate product order reports, and monitor order prioritization. Identify, analyze, and resolve logistical challenges through preparation of management reports that define, evaluate and recommend solutions to these problems. • Apply knowledge of business operations and utilize systems and analysis control principles to perform data analysis for inventory forecasts and demand, and inventory allocation and prioritization. • Identify and compile distribution metrics and modeling to support analysis, evaluation, and implementation of management objectives using scientific knowledge of products and biopharmaceutical quality control practices.

• Improved Portfolio Prioritization by managing a Web-Application and SQL Database with financials from over 400 Molecular Diagnostics Projects from 23 Lifecycle Teams across 3 Business Units. • Positioned a Portfolio Valuation Solution in 3 Diagnostics Business Units.• Conceptualized Analytics Specifications aligned with Business Processes and Planning Systems in use.• Consolidated Product Development Metrics for Key Product Launches.• Trained and partnered with International Product Managers, Finance, and Executive Leadership.

• Coordinated the development of Software Solutions created by vendors for Portfolio Valuation and Tracking of Product Launches.• Designed Analytics for Budget, Project Go/No-Go, P&L, and Capacity Management.• Implemented data visualization using Tableau. • Launched a Portfolio Management Solution for 10 Product Lifecycle Teams of Molecular Diagnostics.

• Developed an Excel model and defined processes for collecting business data for Portfolio Valuation.

Applied Entrepreneurship is a KGI advanced business course with the objective of creating a business plan that can be successfully implemented by a real life sciences company. Our team’s sponsor was Synedgen, Inc., and for this project I was assigned to fulfill the role of Finance Lead. Our business plan focused on attracting VC funding to bring to market a set of products from Synedgen’s Wound Care (SWC) portfolio. This business unit would take the form of a spinoff, with the future options of being acquired or partnering with a big biotech company.My responsibilities and contributions for this project were the following:• Analyzed market intelligence reports to estimate a six-year sales forecast based on the CAGR and accessibility of SWC’s obtainable market segment.• Projected potential gross margins in function of sales growth and scale-up of manufacturing costs by applying Excel's what-if analysis.• Outlined SWC’s development operations and FDA 510K clearances as accomplishable value-enhancing milestones and aligned them with projected funding rounds. • Modeled pro-forma financials of income statement, balance sheet, and cash flows for a six-year period prior to exit. • Applied the VC method with P/E and P/S ratios from S&P 500 and Damodaran data to calculate diverse valuation scenarios for SWC in function of its performance. • Presented an exit strategy with a ten-fold multiple of investment return after six years, and identified potential buyers based on biotech trends.Finally, we delivered a business plan with a flexible financing map and multiple options to bring SWC to profit. Our support might help the founders and investors to foresee ways in which the sequence of milestones SWC is pursuing might lead to new possibilities in the future.

The KGI Team Master's Project (TMP) consists on working with a sponsoring company to solve real problems. Our team was assigned to collaborate with Pfizer’s Diversity Initiative Team and focused on improving the inclusion of diverse patient populations into Pfizer’s clinical trials. Our project’s main objective was to create a community outreach strategy to help clinical sites engage minority organizations. This strategy targeted various stages in clinical trial development where diversity can be better addressed. Some of my responsibilities and collaborations for this project were the following: •Outlined our project’s community outreach strategy into accomplishable milestones and aligned them with their corresponding project deliverables.•Conducted weekly meetings with Pfizer’s liaisons to evaluate progress, document requirements, and explore alternatives for minority engagement. •Provided customer service and better practice materials to 56 clinical trial sites in the United States.•Created an Excel format for 56 clinical trial sites that provides a demographic overview of their location to facilitate the assessment of diversity inclusion in their clinical studies. •Implemented social media monitoring via Brandwatch analytics to track online conversations and trends impacting minority health in the United States.•Provided input for social media communications by constructing easy-to-understand dashboards of topic analysis for emerging issues and trends in minority health. •Established a social media monitoring process that can be implemented as an ongoing and sustainable effort to engage under-represented demographic subgroups. This project established important foundations that will help Pfizer ensure that future clinical trials have participants that represent the epidemiology of the disease being studied.

• Launched a Best Practice Guidance for Product Development Processes across functional areas.The main objective of this internship was to provide guidance about how Roche Molecular Diagnostics' (RMD) products transition from one regulatory category to another. My team was integrated by representatives from Design Quality Assurance, Development Process, Regulatory Affairs and Project Management. Thanks to this team I became familiarized with business process management practices for IA, LSR/GLU, RUO, and IVD products. Some of my contributions to our project were the following:• Mapped complete design control (DC) processes for in vitro diagnostics (IVD) products and assessed them through business process management practices.• Aligned multiple IVDs’ DC processes by their development phases and milestones to facilitate their comparison and assessment.• Created a best practice guidance for the transition of IVD products from one regulatory category to another; IA to LSR/GLU to IVD. • Established a deployment plan and stakeholder management for our best practice guidance to be overseen by a cross-functional team of leading representatives from diverse functional areas.

• Developed a marketing survey to evaluate retail clinics’ receptiveness to new services.• Contacted and surveyed 23 medical directors from six retail clinics.• Generated a market analysis and presented two potential commercial partners.

Ophthalmic Formulations Development - Topical drug deliveryTargeting anterior segment of the eye:• Designed SOP for preclinical stages.Targeting posterior segment: • Achieved above 90% encapsulation rate of therapeutic agent inside the drug delivery system.

Development & Manufacture of Encapsulated Cells Technology - Intraocular Devices.• Addressed multiple clinical cell lines performance.• Innovative device design; achieved stable protein yield in vitro, 70% of previous models. 10-day period with constant cell metabolic activity above 95% (Indicators: Total DNA, CCK8 Dojindo, ELISA, WB, and H&E Stain)

Human DNA sampling;• DNA extraction from human blood.• DNA purification.• SNP detection by sequencing.

Plant biotechnology - Carica Papaya resistant to ring-spot virus• Transgenic embryo selection and maintenance.