Over the previous years that client had experienced an increase in demand of its products. With the broadening of its product portfolio and simultaneously increase in reliance on CMOs, the client was faced with several questions, such as: What is the optimal number of different CMOs, how could the client mitigate the risk from failure of one of the suppliers, how could a change in production schedule best be accomplished with current resources (including CMOs), and what are the most predictive KPIs for any supply chain risk.
• Collected information current supply chain and modelled those into an Event Based Model in simulation software.
• Collected information about current Turn-Around-Times for individual CMO and internal processes, their dependencies and trigger points. Parameterized the model with that information.
• Ran Monte-Carlo simulations with those parameters, identified bottle necks and KPIs for current state.
• Performed what-if scenario analysis assuming failure of CMOs at

The client had found itself in a situation where, practically overnight, it was required to produce and release many 100 of thousands of doses on a weekly basis. The processes for the disposition were inadequate in any aspect, compounded by the presence of a large number of Change Control Items. Embedded in a group of OpEX and External PA professionals.
• Served as a subject matter expert in production processes as a liaison to OpEX
• Served as a SME in compliance issues to help the company to avoid the regulatory pitfalls of hyper charged growth
• Developed data-analytics tools that allows the early identification of upstream risks to supply chain goals and disposition deadlines
• Served as a SME to integrate data from various validated (LIMS, QMS, SAP, MES) and non validated (Smartsheet, Excel) business tools.
• In a second phase, expanded the toolset to include adjacent functional areas, such as QC, manufacturing, and regulatory.
• In a third phase, expanded the toolset to inc

The client found itself in need of qualifying several new production sites while updating existing production sites with the latest seasonal vaccine strains. Worked as compliance and technical SME to a team of OpEX, MST, ext-MFG, ext-QA to develop standardized NPI process, together with policies, SOPs, forms, information systems, wikis, portfolio and program management capabilities, realized in a hybrid of Smartsheet and SharePoint tools.

The client, a US based autologous T-Cell Therapy company, planned a PAI towards the end of 2021. The client had an overriding concern that internal and external production and QC/Micro processes were not strong enough to withstand data integrity scrutiny. The discovery phase of this project was conducted a gap assessment reviewing technical and scientific documents, methods, processes, policies, SOPs, forms, and electronic systems (LIMS, MES). An overarching theme emerged where electronic systems were only implemented partially, requiring operators to switch between paper and electronic systems through many processes. Estimates indicated that significant efficiencies could be gained from going full electronic or full paper, while maintaining better data integrity standards and more control over processes. The discovered gaps were catalogued, categorized and prioritized by risk and perceived gain in effectiveness to lead to better controlled processes.

Several clients faced significant sanctions from the FDA and DOJ for data integrity infractions. The clients were asked to provide proof of data integrity for all individual data points produced often over many years. Further, clients were asked to provide evidence of data integrity remediation protocols and their implementation.
• Led teams to analyze data integrity capabilities of clients in operations and laboratories, develop risk based gap assessments and devise implementation plans (policy, SOPs, technical, training).
• Led teams to implement those remediation plans.
• Developed methodology to use large scale forensic data analysis to analyze all data points for data integrity breaches.
• Led ETL teams and analysis teams across 3 continents simultaneously. Oversaw process to follow-up on likely data integrity breaches using internal and external resources.
• Rescued multiple INDs, reduced number of quarantined lots and positioned companies to re-allow import into US territory.

As part of a data integrity assessment of in Indian client company, reviewed the computer systems validation from the ground up, including the comparison of technical requirements documents with real-life usage. Remediation included a setup of a risk-based CSV framework that ensured the early identification of stakeholders and system owners and realistic assessment of user requirements.

Major US pharmaceutical company
Arrived at the client to find a large number of batches under quarantine, an unsustainable number of open product investigations, regulatory pressure, high staff turnover and a site leadership confused by competing and contradictory information flows. After a series of interviews, it became clear that employees spent too much time reporting data into different systems – in many cases contradicting each other. I developed and implemented a system that integrated the ERP, finance, QMS (Trackwise), personnel scheduling system and others to serve up context specific dashboards to improve management decision making.
• The company went from twice daily "all-hands-on-deck" meetings to twice a week meetings for "manager-and-above" to discuss disposition status of product, freeing up valuable production capacity.
• Enabled company to enter relevant data once-and-once-only throughout the production facility, reducing the existence of contradictory data points.

After DOJ injunction, the client, a US based biotechnology company, submitted to 3rd party oversight of Batch Release (batch record review), and CAPA, Validation and Change Control (Interim Controls). Served as team lead for interim controls working towards:
• Harmonizing output among different reviewers for retrospective and prospective review
• Managed chain of custody of over 60,000 batch record items, 7,500 deviations plus evidentiary documentation, and several 1000 documents for Change control and Validation.
• Managed batch release (each batch consisted of over 300 batch records), while integrating deviation management for batch release.
• Developed database to allow centralized storage of review information and client interaction. Database contained all 60,000+ batch record items, over 7,500+ retrospectively and prospectively reviewed CAPAs, several thousand validation and change control records, over 200,000 observations and responses for a total of almost 1,000 released ba

A German pharmaceutical company had just launched a new to-be blockbuster drug in the cardio vascular disease area. It now looked towards the next decade and beyond to prioritize what products to develop to take advantage of that new momentum.
• Designed interview guides and led a team to conduct more than 50 KOL interviews world wide to understand future unmet medical need in the cardio-vascular and metabolic disease area.
• Built large epidemiology models with focus on Asian market (India, China) owing to a realization that CV and metabolic diseases will impact these countries dramatically in foreseeable future.
• Developed several Target Product Profiles and financial forecasts for these TPPs in various locations based on aforementioned epidemiology.