Advancing Pharmaceutical Innovation: Exploring the Role of Senior Scientists in Process Management at a Modern FLEx Drug Development Center

Introduction

Process management, in the context of daily work for a Senior Scientist - Process Engineer at a modern, multi-modality Drug Product development and GMP clinical manufacturing plant like the Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, is a fundamental approach to excellence. At its core, process management involves a thorough understanding and application of methodologies that aim to refine and enhance the complex scientific processes integral for the development of small molecules, biologics, and vaccines.

Embedded within this framework is the systematic analysis and thoughtful design of experiments and laboratory operations, ensuring that every step—from initial research to clinical manufacturing—is executed with precision and in accordance with strict regulatory standards. This not only encompasses the supervisory aspects of GMP compliance but also involves a continuous pursuit of process optimization.

By deploying advanced tools for process modeling, performance measurement, and process automation, a Senior Scientist - Process Engineer embeds an ethos of perpetual improvement in standard operating procedures. Daily responsibilities, thus, revolve not only around conducting and supervising experiments but also around meticulously evaluating and refining procedures to maintain alignment with the dynamic nature of drug development, ensuring both quality and efficiency in the quest to bring innovative therapies from the lab bench to clinical relevance.

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

What is KanBo?

KanBo is a comprehensive work coordination platform designed to facilitate task management, work visualization, and efficient communication within organizations. It integrates with Microsoft ecosystems like SharePoint, Teams, and Office 365, offering a robust environment for tracking projects, workflows, and collaborative efforts.

Why?

KanBo provides a flexible and customizable process management tool that aligns with various work methodologies and integrates deeply with the Microsoft suite, therefore optimizing workflow and productivity. Its capability to handle complex project hierarchies, store sensitive data securely on-premises, and its real-time updates ensure effective task tracking, accountability, and oversight of process development.

When?

KanBo should be employed when process management requires precise organization, the coordination of tasks among team members, and seamless communication. It is especially beneficial when there is a need to visualize intricate workflows, manage a large number of tasks, or collaborate across different departments or geographical locations.

Where?

KanBo can be used in both cloud-based and on-premises environments, making it suitable for diverse settings that adhere to various data management policies and compliance requirements. It is accessible through web browsers and is integrated with other Microsoft Office tools, meaning it can be used anywhere with internet access.

Should a Sr. Scientist - Process Engineer use KanBo as a Process Management tool?

Yes, a Sr. Scientist - Process Engineer should consider using KanBo as it offers a structured and transparent way to manage scientific processes, experiments, and R&D projects. With its hierarchical setup, KanBo allows for categorization of work into workspaces, folders, spaces, and cards, which can represent different stages of a scientific project. The tool's features such as Gantt charts, card relations, and forecast charts enable detailed planning and tracking of process development. This can efficiently bridge the gap between experimental design, execution, and result analysis, ensuring continuity and scalability in scientific research and engineering processes.

How to work with KanBo as a Process Management tool

Instructions for a Sr. Scientist - Process Engineer on How to Use KanBo for Process Management in a Business Context

1. Create a Workspace dedicated to Process Optimization:

Purpose:

To establish a centralized location for all process-related activities, facilitating better organization and focus.

Why:

A dedicated workspace ensures that all process-related information is accessible in one place, increasing the visibility of process flows and enabling better communication among team members.

2. Develop a Space within the Workspace for Each Core Process:

Purpose:

To break down the business's core processes into manageable segments, allowing for granular control and tracking of each process.

Why:

Segmenting processes into separate spaces helps isolate and address specific process characteristics and performance metrics, making optimization efforts more targeted and effective.

3. Utilize Cards to Represent Individual Process Steps:

Purpose:

To map out each step of a process and assign tasks, responsibilities, and deadlines, enabling clear delineation of workflow.

Why:

Visual representation of steps helps identify areas of inefficiency or bottlenecks and provides an overview of the progression of process optimization efforts.

4. Apply Card Grouping to Categorize Process Phases and Types:

Purpose:

To organize cards according to logical groupings based on their stage in the process or their nature (e.g., measurement, analysis, improvement).

Why:

Grouping facilitates easier navigation through the process steps and enhances the ability to monitor related sets of activities, contributing to cohesive process management.

5. Monitor Card Activity Stream for Transparency in Process Changes:

Purpose:

To track all updates, contributions, and communications related to a process step in real-time.

Why:

Keeping an activity stream creates an audit trail of process-related changes, deepening the understanding of the process evolution and fostering continuous improvement by capturing insights from each change.

6. Identify and Address Card Blockers to Resolve Process Issues:

Purpose:

To pinpoint and categorize obstacles that hinder process flow, allowing for swift problem-solving actions.

Why:

Recognizing and classifying blockers enable the Process Engineer to systematically tackle issues preventing process advancement, which is crucial for achieving optimal process conditions.

7. Manage Card Relations to Understand Dependency and Workflow:

Purpose:

To create a map of how tasks and process steps are interrelated, defining dependencies and sequences.

Why:

Understanding the relationship between different process components helps to anticipate the impact of changes and coordinate steps to maintain smooth operations.

8. Assess Card Statistics for Performance Analysis:

Purpose:

To gather data on process performance, identify trends, and measure the effectiveness of optimization efforts.

Why:

Continuously analyzing performance statistics is essential for validating process improvements, identifying new opportunities for enhancement, and making data-driven decisions.

9. Track Dates in Cards for Project Management:

Purpose:

To keep a record of important milestones, deadlines, and reminders for each process step.

Why:

Maintaining a timeline ensures that process optimization tasks are completed on schedule, which is critical for the timely achievement of operational goals.

10. Review and Plan with Gantt Chart view:

Purpose:

To project all time-dependent steps on a visual timeline, allowing for sophisticated, long-term scheduling and planning.

Why:

A Gantt Chart view facilitates the understanding of the entire process timeline, dependencies between tasks, and resource allocation, enabling the strategic planning of process optimization efforts.

KanBo can be a powerful ally for a Senior Scientist - Process Engineer committed to driving process excellence. By leveraging KanBo's structure and features, your role will encompass more than just managing tasks - you will be architecting processes that enhance productivity, reduce waste, and create a resilient operational backbone for your organization.

Glossary and terms

Here is a glossary of terms related to process management and the KanBo platform, excluding any specific references to the company Merck:

Glossary of Terms:

1. Process Management - The practice of overseeing the lifecycle of business processes to ensure they are efficient, effective, and aligned with organizational goals.

2. KanBo - A digital platform that helps manage and coordinate work by visualizing tasks within customizable boards, lists, and cards, deeply integrated with Microsoft's suite of products.

3. Workspace - A collection of spaces in KanBo that pertain to a particular project, team, or thematic area, providing a collaborative environment for related tasks and discussions.

4. Space - A container in KanBo that consists of cards organized to represent specific workflows or projects. It is within this environment that collaboration on the project or task level occurs.

5. Card - The basic unit in KanBo representing an individual task, idea, or item, which can contain details such as descriptions, due dates, attachments, and comments.

6. Card Status - An indicator that defines the stage or phase of the task within a KanBo card, such as "To Do," "In Progress," or "Completed," allowing for easy tracking of work progress.

7. Card Activity Stream - A log of all actions taken on a KanBo card, providing real-time updates and a historical record of changes and communications.

8. Card Blocker - An identified factor that impedes progress on a task within a KanBo card, hinders workflow, and needs to be addressed for the work to continue.

9. Card Grouping - The method of organizing KanBo cards according to specified criteria such as status, assignee, or due date, to structure and navigate tasks more effectively.

10. Card Issue - A problem associated with a KanBo card that affects its management or completion, typically highlighted by color coding for quick identification.

11. Card Relation - A dependency link between KanBo cards that establishes a relationship, showing how tasks are interconnected and the sequence in which they should be addressed.

12. Card Statistics - Analytical data within KanBo that provides insights into tasks' lifecycle, performance metrics, and overall efficiency.

13. Dates in Cards - Various date markers in KanBo cards that represent important timelines for tasks such as start dates, due dates, and reminders.

14. Completion Date - The date on which a KanBo card's status is marked as "Completed," signifying the end of work on a particular task.

15. Default Parent Card - The primary card in a set of linked KanBo cards that serves as the main reference point for a more extensive task subdivision.

16. Forecast Chart View - A visual representation in KanBo that delivers projections about the workflow, helps anticipate project progression, and supports planning and resource allocation.

17. Gantt Chart View - A KanBo view that displays tasks on a timeline, helping to visualize project schedules and dependencies between tasks over time.

18. Grouping - A collective term in KanBo for various methods used to organize cards by associating them with common parameters for better management and operational visibility.

19. List - A customizable field in KanBo that helps categorize cards into distinct groups for improved organization, with each card being able to belong to only one list at a time.

This glossary provides fundamental concepts that can help users navigate and understand the features and functionalities of KanBo for process management tasks.