Northreach have partnered with an exciting pharma company based in the UK that are recruiting for a MSAT Project Manager to join their team. In this Technical Transfer project management role, you will be utilizing your considerable scientific knowledge to deliver successful inbound and outbound technical transfers of manufacturing of our vital medicines.
Key Activities / Key Responsibilities
* Act as the MSAT technical expert in cross-functional projects, managing technical aspects across Supply Chain, Integration, M&A, Regulatory, and Commercial teams.
* Lead technical communication with manufacturing sites, evaluating and overseeing proposed technical projects.
* Provide scientific input on procurement discussions, including one-off costs and CoGs, and prepare purchase orders.
* Plan and execute manufacturing site transfers, supplying critical technical information to support successful registration within compliance, timelines, and budgets.
* Offer technical support to address compliance, quality, and technical issues at CMOs and CROs.
* Ensure CMO sites optimize product performance using technical expertise.
* Support internal regulatory teams in addressing batch failures, variations, or recalls involving Regulatory Authorities.
* Review and approve technical documentation, including product quality data, certificates, stability data, and risk assessments.
* Conduct technical due diligence for potential M&A targets, assessing manufacturing complexity and transfer feasibility.
* Maintain and update internal documentation, ensuring adherence to safe and established procedures.
* Raise and manage Change Control Requests, ensuring compliance with SOPs and internal processes.
If you believe you've got what it takes, please apply and we will speak soon.