Job Description
Proclinical is currently working alongside a pharmaceutical company seeking a MSAT Project Manager - Small Molecule to join the team. This is a hybrid role in Ascot, Berkshire.
Role Overview
1. Utilize deep technical expertise to lead communications with new and existing manufacturing sites, while evaluating and providing insights on proposed technical projects.
2. Serve as the technical expert for the MSAT department in cross-functional projects, overseeing all technical aspects of portfolio initiatives and collaborating with Supply Chain, Integration, M&A, Regulatory, and Commercial teams.
3. Offer scientific and technical support to internal and external stakeholders to resolve issues related to compliance, quality, and technical challenges across CMOs and Contract Research Organizations (CROs).
4. Provide scientific and technical input to procurement for assessing one-time costs and proposed Cost of Goods (CoGs) during negotiations with Contract Manufacturing Organizations (CMOs). Prepare and issue purchase orders as needed.
5. Ensure optimization of product performance at CMO sites by applying technical expertise.
6. Support internal regulatory teams in engaging with Regulatory Authorities, addressing batch failures, and managing specific variations (BSVs) and activities associated with batch recalls.
7. Drive site-to-site manufacturing transfers by sharing criti...