MSAT Project Manager - Small Molecule (Hybrid Working)

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

• 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). Prepare and issue purchase orders as needed.
• 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.
• Drive site-to-site manufacturing transfers by sharing critical know-how, technical information, and documentation, while addressing CMC-related inquiries to facilitate successful new site registrations within established compliance, timelines, and budget constraints.
• 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.
• Maintain and update internal documentation, ensuring proper upload of information to shared folders while adhering to safety protocols.
• Conduct technical reviews and due diligence for target medicines identified in M&A initiatives, assessing manufacturing complexity, transfer timelines, and potential risks or limitations.
• Initiate and manage Change Control Requests while ensuring adherence to standard operating procedures (SOPs) and internal processes.

Qualifications and Experience

• 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.
• Experience working with both biologics and small molecules.
• Proven success in project management and execution, including site technical transfers.
• Global experience in manufacturing, regulatory registration, and pharmaceutical distribution.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.