Optimizing Global CMC Development: Embracing Advanced Data Science in the Pharmaceutical R&D Ecosystem

Introduction

Process management in the context of daily work for a Principal Data Scientist involves the methodical oversight and refinement of analytical and operational workflows that underpin data-driven decision-making and problem-solving within an organization's R&D department. As a Principal Data Scientist, one is responsible for ensuring that the model building, data analytical processes, and computational algorithms employed align with the broader strategic objectives of the organization's Global CMC (Chemistry, Manufacturing, and Controls) Development operations.

This role entails identifying and developing innovative data-driven methodologies to support process development, from the early stages of molecule selection through to the technological transfer to commercial production. With the goal of enhancing efficiency and fostering evidence-based conclusions, the Principal Data Scientist will design and continuously improve standardized methodologies to analyze large, complex datasets, automate workflows, and integrate advanced analytics into the fabric of the organization's scientific processes.

The daily work involves not only the application of statistical and machine learning techniques but also the management of cross-functional teams and the provision of technical guidance across projects. The Principal Data Scientist will also play a pivotal role in promoting a culture of quantitative rigor, ensuring that process integrity, reproducibility, and scalability are maintained across all data science initiatives within the CMC activities at the organization's various locations.

KanBo: When, Why and Where to deploy as a Process Management tool

What is KanBo?

KanBo is an integrated work coordination platform, designed to manage processes through visualization, task management, and effective collaboration. Emphasizing hierarchy, it utilizes Workspaces, Folders, Spaces, and Cards, structured to capture the entirety of a workflow or project.

Why?

KanBo consolidates complex workflows into an intuitive interface, fostering transparency and accountability. It offers hybrid data management with on-premises and cloud flexibility, deep integration with Microsoft products, and enhanced customization. It enables progress tracking, expectation setting, and resource optimization.

When?

KanBo should be used when managing numerous tasks, coordinating teams, allocating resources, tracking progress, and aiming for improved productivity. It’s particularly useful when process control and adaptability to changing conditions are required, or when remote collaboration is essential.

Where?

KanBo can be deployed within any internet-accessible environment, as it is supported on cloud platforms and on-premise systems. It is accessible from various devices, ensuring team members can operate from different locations, ensuring continual workflow management and communication.

Should a Principal Data Scientist use KanBo as a Process Management tool?

A Principal Data Scientist should leverage KanBo due to its ability to manage complex data projects, from initial conception to post-deployment analysis. With in-built analytics for task management and its facility for customization, it can be tailored to suit predictive modeling, machine learning workflows, research and development projects, and data governance processes. The hierarchical organization allows for effective segmentation of tasks, ensuring clear delineation of responsibilities and milestones, which is crucial for projects that demand precision and meticulous tracking. Additionally, KanBo’s emphasis on collaboration and documentation aligns with the needs of a data science team that may require iterative feedback and collective decision-making.

How to work with KanBo as a Process Management tool

As a Principal Data Scientist, leveraging KanBo for process management can help streamline and enhance the process optimization efforts within a business context. Here are the steps on how to use KanBo for this purpose:

Step 1: Define the Process Workflow

Purpose: The first step is to define the end-to-end workflow of the specific business process you aim to manage and optimize.

- Why: Understanding the current state of the workflow is essential for identifying areas of inefficiency and setting a foundation for process improvement.

Instructions:

1. Within KanBo, create a new workspace dedicated to process management.

2. Establish Folders within the workspace to categorize different business processes.

3. For each process, create a Space that encapsulates all steps of the process.

Step 2: Model the Process

Purpose: To visually represent the process to better understand its components and identify potential bottlenecks.

- Why: A visual model aids in communicating the process across the team and provides clarity on roles and responsibilities.

Instructions:

1. Utilize KanBo's Board view to model the process using Cards to represent each step or task.

2. Each Card should have a status column that aligns with the flow of the process, such as "Not Started," "In Progress," and "Completed."

Step 3: Measure Process Performance

Purpose: To capture and analyze data related to the efficiency and effectiveness of the process.

- Why: Data-driven insights enable the identification of performance gaps and support informed decision-making for process optimization.

Instructions:

1. Use KanBo Cards to log time, cost, output quality, and other relevant process metrics.

2. Define Custom Fields within Cards to capture specific data points necessary for process analysis.

3. Leverage KanBo's Card statistics to monitor and review performance indicators.

Step 4: Analyze the Process

Purpose: To interpret the data collected to determine where the process can be optimized.

- Why: This analysis reveals inefficiencies, duplicated efforts, and unnecessary steps that can be eliminated or improved.

Instructions:

1. Use Card relations to visualize dependencies and evaluate the impact of one step on another.

2. Monitor the Card activity stream for real-time insights into process flow and potential delays.

Step 5: Implement Improvements

Purpose: To apply the findings from the analysis to make strategic adjustments to the process.

- Why: Continuous improvement ensures that the process stays efficient, adaptable, and aligned with business goals.

Instructions:

1. Adjust the process workflow in the KanBo space to reflect improvements or new steps.

2. Utilize Card templates to standardize new optimal practices across the process.

Step 6: Automate and Monitor

Purpose: To introduce automation for repetitive tasks to increase process efficiency and reduce human error.

- Why: Automation allows the business to scale operations effectively and frees up valuable resources for more strategic activities.

Instructions:

1. Identify parts of the process suitable for automation.

2. Set up Card triggers and actions to automate movement through the workflow based on predefined conditions.

3. Employ the Gantt Chart view or Forecast Chart view to oversee the entire process and ensure adherence to timelines.

Step 7: Continuously Improve

Purpose: To maintain a culture of constant enhancement, adjusting the process as new opportunities for optimization arise.

- Why: Sustainability and competitiveness rely on the ability to evolve processes in response to internal and external changes.

Instructions:

1. Actively seek feedback using KanBo’s commenting features on Cards to gather insights from team members.

2. Regularly assess process performance with KanBo’s reporting tools and make iterative changes for ongoing refinement.

By systematically applying these steps in KanBo, you as the Principal Data Scientist will be able to execute robust process management practices that can drive business process optimization and contribute to the strategic success of the organization.

Glossary and terms

Certainly! Here's a glossary with explanations of the terms related to KanBo, a work coordination platform:

Workspace: An organizational entity within KanBo that groups together a set of Spaces related to a particular project, team, or theme, providing a centralized location for related tasks and facilitating easier navigation and collaboration.

Space: Within Workspaces, Spaces are collections of Cards that are arranged to visually represent workflows. Spaces can represent projects or areas of focus for a team, and they play a key role in managing and tracking tasks and fostering collaboration.

Card: The most granular unit within KanBo, a Card represents an individual task, item, or piece of work. Cards include information such as notes, files, comments, due dates, and checklists and can be customized to suit different types of tasks or workflows.

Card Status: This term refers to the progress stage of a Card within KanBo. Statuses such as "To Do," "In Progress," and "Completed" help organize and manage work by showing where each task is in its lifecycle.

Card Activity Stream: A real-time log of all actions and updates related to a specific Card. The stream displays a chronology of changes and interactions with the Card, providing transparency and insight into task progress.

Card Blocker: An element that signifies an issue or obstacle preventing a Card from progressing. Users can highlight standstill reasons with local, global, or on-demand blockers, helping to identify and categorize work impediments.

Card Grouping: A feature that enables the categorization of Cards based on criteria such as status, assignee, or due date. Grouping helps organize tasks within a Space, improving efficiency and clarity.

Card Issue: Problems associated with a Card that hinder effective management, often highlighted with colors to denote urgency or priority—such as orange for time conflicts or red for blockers.

Card Relation: The linkage between Cards indicating dependencies or sequential relationships. Parent-child or next-previous are common types of card relations, establishing an order and hierarchy for task completion.

Card Statistics: An analytical feature providing visual data on a Card's lifecycle, including charts and hourly summaries, to help users understand the process of task realization in KanBo.

Dates in Cards: Terms used to identify time-related aspects of a Card, such as start dates, due dates, and reminders. These dates mark important task timelines or milestones.

Completion Date: The date when a Card's status is changed to "Completed," often visible on the Card's front for easy reference.

Default Parent Card: Among multiple parent cards, one is designated as the default, representing the main task or project associated with a child Card.

Forecast Chart View: A visualization tool displaying project progress and providing forecasts based on past performance, useful for tracking completed and remaining tasks against project timelines.

Gantt Chart View: This Space view displays time-dependent Cards on a timeline in a bar chart format, suitable for planning and managing complex, long-term projects.

Grouping: A way to classify related Cards into distinct categories within a Space. Groupings help manage and organize Cards and can be based on attributes such as assignees, card statuses, or custom fields.

List: A custom field type in KanBo that enables users to categorize Cards, ensuring each Card is assigned to only one List, thus facilitating organized task management.

Understanding these terms will assist users in navigating KanBo and leveraging its features for effective process management, collaboration, and execution of tasks within an organization.