CDMO Project Management - Transparency & Timeliness
The Goodwin Biotechnology project management approach is based on the value we have found through open communications with our Subject Matter Experts (SMEs) – a level of transparency that we’re sure you’ll find refreshing. This level of transparency is critical for the timely completion of your complex biopharmaceutical project.
Project Management Overview
As part of the foundation for every project, Goodwin Biotechnology assembles a Project Team with a single Project Manager (PM) as the point-of-contact. Your PM is an experienced CDMO project management veteran in biological manufacturing and will be the advocate for you within Goodwin Biotechnology to ensure that project timelines are met and that information is communicated, both ways, in a timely manner.
- Before initiating your project, a kick-off meeting will be held at Goodwin to review information you have provided and to introduce the Project team. The project scope and the project plan with project timeline will be established, agreed upon and serve as a guide for all activities throughout the program.
- Beginning with the kick-off meeting and continuing during all phases of the project, the PM will coordinate weekly or biweekly meetings with you, the Goodwin Project Team and SMEs, as appropriate, in order to communicate the progress of the project and discuss the path forward. The Project Team will review the timeline, action items, and follow-up on action items from the previous week. Additional sub-team meetings or additional invited SMEs will be scheduled for upstream, downstream, or analytics, as necessary.
- To ensure adherence to set schedules and timelines (Gantt) for completion of the project, the PM will use systems for internal project monitoring such as internal project status meetings and project checklists among other tools.
What Clients Say
“I have found that working with the team at Goodwin Biotechnology has been a great pleasure. We were originally impressed by their expertise in Bioconjugation. This perception was reinforced by the flexible and solution-oriented approach to the complexity of our project. They treated our product as theirs as they orchestrated a flexible and well-run process. This is our company’s first IND submission and securing the IND was a crucial milestone for our company. It speaks about the quality, timeliness, and process economics that Goodwin puts into every aspect of their work.”
The Goodwin Project Manager (PM) will be assigned as an advocate for you and will ensure that all tasks are completed on time. Goodwin will communicate with you through a single Goodwin Project Manager (PM) as the point-of-contact. The PM will provide real time status of the project. The PM will coordinate the activities for the Goodwin Project Team of Subject Matter Experts ( SMEs) assigned to your project and adhere to a well defined Client Engagement Model.
The “Goodwin Delivers” Approach
For nearly 30 years, Goodwin has honed its overall experience and expertise in the process development, scale-up, cGMP manufacturing, fill and finish of biopharmaceuticals such as monoclonal antibodies and other recombinant proteins as well as Antibody Drug Conjugates (ADCs). Throughout this time we have found the basis / foundation of a solid Goodwin / Client Partnership begins with a sound CDMO Project Management approach.
High Level of Transparency
Contact us for more information on how our Project Management services can provide you with the highest level of transparency for your project.