Program Management Leadership in Complex NGS Transfers
Overview
Arjan Roozen was engaged by a leading international CRO to fill the role of Program Manager and report to Erik Splinter, who is the General Manager of Solvias NL. His assignment involved overseeing and organizing the assay built of two NGS viral safety assays, a NGS Vector ID assay and the TLA Capture assay at the Utrecht site and the tech transfer of the assays to the Solvias RTP site in the US. His strong background in advanced therapies, senior operational management roles and internal and external stake-holder management experience enabled him to immediately provide effective oversight and continuity in a complex, multi-site environment.
Objective
The primary objective of his assignment was to facilitate the assay built of two NGS viral safety assays, the NGS Vector ID assay and the TLA Capture assay at the Solvias Utrecht site and manage the interface alignment between the Solvias NL and Solvias RTP site in the US to transfer the developed NGS assays.
Key Challenges & Approach
The assignment posed several challenges due to the complexity of the NGS assay development trajectory and interface alignment between two sites as well as stake holder management and managing expectations to sponsors and reporting lines. Arjan had to quickly adapt to the internal expectations of the sponsors while simultaneously establishing effective working relationships with the Solvias Utrecht team and Solvias RTP team in the US.
His approach was methodical and structured. He began by bringing the sponsors together with the Solvias Utrecht team to perform an assessment of existing NGS assay development status and corporate expectation. Agreements were made with the sponsors and project management tools were identified and mobilized to manage the so called ‘UTR Assay Master Plan’ . Whereby the development of the NGS assays in Utrecht and the tech transfer to RTP in the US was mapped out and turned into an executable roadmap with timelines and deliverables. Reporting to the sponsors was organized using a monthly score card.
Execution
Within the first weeks, Arjan integrated himself into the Solvias organization and Utrecht team and aligned closely with key stakeholders. He facilitated cross-functional discussions within the Solvias Utrecht team and corporate Solvias organization and took a proactive role to understand the status of the NGS assay development status and manage the sponsor expectations.
Arjan introduced steering committee meetings and planning workshops to make sure that decisions were taken timely and surfacing challenges were solved on time, minimizing the impact on the agreed timelines and deliverables.
Conclusion & Lessons Learned
His assignment highlights the critical role of experienced senior professionals in ensuring that complex assay development trajectories and site tech transfers are executed according to plan and sponsor expectations. This case demonstrates the strategic value of assigning senior project management roles within global organizations with complex assignments to successfully organize and manage cross site development and tech transfer projects.
