Project Management

Introduction

SynCo envisages a close collaboration between the client and SynCo and considers that such collaboration will be vital to the success of the project.  The client has an abundance of knowledge about their products and manufacturing process and this knowledge needs to be captured and put to good use during the process transfer and scale-up phases of the project. 

SynCo has built up a vast experience in developing collaborative relationships with many organizations worldwide and SynCo’s project management systems and processes focus on ensuring:

• Strong involvement of the client’s scientific and project management organization in setting up clear project goals, objectives and deliverables
• Frequent and open communication between the teams at SynCo and our clients, through regular project team and steering committee meetings to ensure that at every stage, the client has the fullest possible understanding of the progress of the program
• Collaborative decision-making, where necessary, if the results dictate a change of direction or priorities within the project.

A full program of process and analytical transfer and/or development, qualification/validation and GMP manufacturing will typically involve numerous people from both companies at all levels in each of the different functional areas.  The information flow, expertise and advice in various communication formats within the internal organization, and to and from the client, is managed by the Project Manager leading multi-disciplined project teams. 

To determine if predefined success criteria have been met and we can proceed to the next phase of the project, SynCo uses an efficient and ‘gate-defined’ project management system, involving both SynCo and the client in making the final ‘go / no-go’ decisions. Overall SynCo has established a robust yet flexible project management system that allows SynCo together with its clients to achieve the set milestones and in the end the success of the product. You therefore can “Trust us to make it right”. 

Project Team 

SynCo’s Operational Management will assign a project team consisting of the following key personnel selected on a best fit basis considering the individual’s expertise and experience for the project in hand: 

Project Manager – a dedicated Project Manager, who is client focused with experience in being involved and leading cross-functional project teams is assigned to the project. This Project Manager will be responsible for day-to-day communications internally and externally and coordination of all project team activities in line with the contracted deliverables and scope of work. 

Project leads Process Transfer and Development – typically an upstream (fermentation/cell culture) expert and downstream (purification) expert will lead the process technology transfer and development elements of the program. Typically these team members will work closely with the client’s process experts from the start of a project and will follow the process from transfer and/or development through scale up into the GMP facility when the initial GMP batches are produced. 

Project leads Manufacturing (MF) – these team members will lead the fermentation/cell culture, harvest and purification GMP production elements of the project in close collaboration with the process transfer and development project leads to ensure that the process is robust and scalable, GMP ready, with quality and the longer term vision of the product in mind. 

Project lead Analytical Development – an analytical development expert will be part of the project team when analytical methods need to be developed during the project. The analytical development expert will work in close collaboration with the client’s analytical expert and SynCo’s project lead Quality Control to make sure the developed methods are suitable for the intended use and can be qualified/validated by the Quality Control department. 

Project lead Quality Control (QC) – the QC project lead will liaise with SynCo’s project lead analytical development and the client’s analytical experts for the transfer, qualification and/or validation of the analytical methods. They will work closely together to evaluate that any transferred and/or developed methods are fit for purpose and can be qualified/validated for GMP batch QC release testing to ICH guidelines. 

Project lead Quality Assurance (QA) – this team member is responsible for managing all of the internal quality and compliance aspects of the project and execution of the Quality Agreement i.e raw material release, GMP and QC documentation, manufacturing and product specifications, following a process of internal and external input and review by both SynCo and the client. This team member directly reports to SynCo’s Qualified Person facilitating GMP batch release. 

Project lead Fill and Finish (FF) – when aseptic filling and finishing is part of the project a project lead Fill and Finish will be part of the project team. This team member will amongst others make sure GMP documentation is ready, reviewed and approved by the client before the fill is performed. 

Business Development Manager (BDM) – the BDM who led and managed the proposal generation and bidding process, becomes a project team member at a steering committee level.  The BDM is responsible for account management of all commercial aspects and business risks of the project, ensuring that the expectations of both the client and SynCo are managed and aligned in successfully achieving the project objectives. 

Typically these core project team members are highly visible and will form direct links to their counterparts within the client’s organization.  Site visits of the client’s scientists to SynCo and visa-versa are strongly advocated by SynCo to maintain visibility and support the respective technology transfer and production phases and overall success of the project.

Project team meetings

Throughout the full project term at SynCo, you can expect weekly operational conference calls between the technical project team members and monthly steering committee meetings. At the monthly steering committee meetings, senior members of both project teams will meet to discuss the higher level progress of planned activities, mitigate risks and proactively manage critical path items to support the successful delivery of key contracted deliverables within budget and on time. 

The steering committee is supporting the operational project team by: 

• Managing risks, quality, timelines and a good working relationship.
• Assessing formal requests for change to the scope and budget of the project.
• Evaluating and approving project expenditure.

The ultimate aim is to keep the project moving, whilst retaining flexibility and avoiding surprises by keeping items off the critical path.