Data Project Management Officer

4 days ago


Ascot Berkshire, United Kingdom Proclinical Staffing Full time

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.

Utilize deep technical expertise to lead communications with new and existing manufacturing sites, while evaluating and providing insights on proposed technical projects.
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.
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).
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). Ensure optimization of product performance at CMO sites by applying technical expertise.
Support internal regulatory teams in engaging with Regulatory Authorities, addressing batch failures, and managing specific variations (BSVs) and activities associated with batch recalls.
Review and approve key technical documents related to product Marketing Authorizations (MAs), such as product quality documentation, certificates of analysis, stability data, batch manufacturing records (BMRs), product quality reviews (PQRs), and risk assessments.
Conduct technical reviews and due diligence for target medicines identified in M&A initiatives, assessing manufacturing complexity, transfer timelines, and potential risks or limitations.
Bachelor's degree (or higher) in Life Sciences such as Pharmacy, Pharmaceutical Sciences, or Chemistry.
Certification in Project Management (e.g., PRINCE2, PMP, or equivalent).
Extensive experience in site technical transfers, encompassing pharmaceutical manufacturing, QC testing, and packaging processes, including serialization.
Proven success in project management and execution, including site technical transfers.
Global experience in manufacturing, regulatory registration, and pharmaceutical distribution.



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