Senior Pharmaceutical Project Leader

2 days ago


Ascot, Windsor and Maidenhead, United Kingdom Proclinical Staffing Full time
Job Overview

This is a hybrid role in Ascot, Berkshire. The successful candidate will lead communications with new and existing manufacturing sites.

  • Technical expertise to evaluate and provide insights on proposed technical projects.
  • Serve as the technical expert for the MSAT department in cross-functional projects.
  • 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).

Key Responsibilities:

  • Apply technical expertise to optimize product performance at CMO sites.
  • 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.

Requirements:

  • Bachelor's degree 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.

The estimated salary for this position is £80,000 - £100,000 per year, depending on experience.



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