Contract MSAT Project Manager

Essential Pharma are looking for an Contract MSAT Project Manager . We outsource all test, pack and manufacture so your role will be crucial in the successful management and closure of 3 ongoing tech transfers. Apply today! What You Will Do Represent the MSAT department in cross functional projects and manage all technical aspects of three key projects, working with Supply Chain, Integration, M&A, Regulatory and Commercial departments. Leverage your extensive technical background to lead technical communication with new and existing manufacturing sites. Execute site – to – site manufacturing transfers, providing critical know how as well as technical information (CMC), documentation and support to achieve successful new site registration within compliance and agreed timelines and costs. Build key relationships with internal and external stakeholders to solve technical, compliance and quality issues in conjunction with various activities at CMOs, CROs and for regulatory authorities addressing batch failures and/or specific variations (BSVs) and activities relevant to batch recalls. Review and approve relevant technical documentation with reference to the product’s MA. This includes product quality documents, certificates of analysis, stability data, BMRs, PQRs, as well as risk assessments. What We Do Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries. We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio. Our UK Operations team is comprised of 60 people, based out of our Egham, Surrey office, five minutes’ drive from Egham Train Station situated on the Thorpe Industrial Estate. We also have colleagues based in Malta, France, Spain and Switzerland. What You Will Bring Significant experience across all aspects of tech transfer and the management of CMOs. Experience across biologics and small molecules – small molecule established brands / mature products will be highly valuable. Global exposure to manufacturing, registering and distributing pharmaceuticals. The ability to travel when required, most of our partners are based Europe and our head office is based in Egham, Surrey. What We Offer Quick start Competitive rate outside IR35