SynCo has vast experience in developing collaborative relationships with organizations worldwide. This has enabled us to develop project management systems and processes that are focused entirely on:
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Establishing close working relationships with our clients’ scientific and project management staff in setting project goals, objectives and deliverables
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Maintaining close and open communication between the teams at SynCo and our clients, through regular "steering group" meetings to ensure that at every stage, the client has the fullest possible understanding of the progress of the program
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Collaborative decision-making, where necessary, if the results dictate a change of direction or priorities within the project
As a result of this approach, SynCo Bio Partners has grown steadily through the last ten years in a very competitive market by establishing strong and mutually beneficial relationships with our clients. For some, this has been expressed through long term supply agreements, while for others it means coming back to SynCo every year for new manufacturing projects.
A full program of process development and GMP manufacturing will involve around 100 different people, and a range of expertise and advice will be needed. To ensure projects run smoothly at times, we implement an efficient and ‘gate-defined- project management system, involving both
Project Team
Project manager - Following the selection of SynCo as your CMO, SynCo will assign a project manager. This project manager will be responsible for day-to-day communications and coordination of project team.
SynCo’s project manager will then assign a project team consisting of the following key personnel:
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Project lead Analytical and Process Development (APD) – this person will lead the technology transfer, analytical and process development elements of this program. Typically this team member will work closely with the client’s process experts throughout the project.
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Project lead Manufacturing (MF) – this team member will lead the GMP production elements of the project and will liaise closely with the process development project lead to ensure that the developed process is transferred smoothly to SynCo’s GMP facilities. This project team member is also responsible for ensuring that the process developed is feasible for long term GMP production.
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Project lead Quality Control (QC)– the QC project lead will liaise with the client’s QC department in the transfer of existing qualified or validated assays. Where an assay is newly developed, this project lead will work closely internally at SynCo with the project lead APD to ensure that the developed assays are suitable for use in an GMP environment and can be validated.
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Project lead Quality Assurance (QA) – this team member is responsible for the Quality aspects of the project, e.g. ensuring that GMP documentation is reviewed internally and by the client on an appropriate timeline. This team member will also liaise with the client on the setting of GMP specifications.
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BD/Account manager – this team member is responsible for all commercial aspects of the project.
Typically these core project team members are highly visible and will form direct links to like minded people within your organization.
Steering Committee
Throughout your program, weekly conference calls and monthly steering committee meetings will be held between key project members from your company and SynCo. At each monthly steering committee meeting, senior members of each project team will meet to discuss the progress and planned activities.
The project Steering Committee has control over all aspects of the project, including business aspects associated with the project that are essential to ensuring the delivery of the project.
This includes:
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Monitoring risks, quality and timelines
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Assessing requests for change to the scope of the project
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Evaluating and approving project expenditure
Typically the members of the committee are of sufficient seniority to be able to make binding decisions. The aim is to keep the project moving, whilst retaining flexibility.