MSAT Project Manager

2 months ago

UK, UK, United Kingdom Essential Pharma Full time

Essential Pharma are looking for a new MSAT Project Manager. We outsource all test, pack and manufacture so your role will be crucial in driving the best out of our partners (CMOs, CROs) and delivering successful inbound and outbound technical transfers, securing the supply of vital medicines to patients. We have a strong history of acquiring Established Brands and offer a growing portfolio in rare disease and clinical stage assets. Apply today


What You Will Do


  • Represent the MSAT department in cross functional projects and manage all technical aspects of our portfolio 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 to review and appraise proposed technical projects.
  • Initiate, plan and 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 product’s MA. This includes product quality documents, certificates of analysis, stability data, BMRs, PQRs, as well as risk assessments.
  • Work closely with M&A to manage technical reviews and due diligence of target medicines for potential acquisition initiatives. This technical assessment will include complexity of manufacturing, transfer lead times, potential limitation and risk identification.
  • Drive the use of analytical data collated from CMOs and internal studies to make adaptations and improvements to manufacturing processes to support product growth, efficiency or the acquisition or divestment of our product portfolio.


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 in site tech transfer including wide exposure to pharmaceutical manufacturing, QC testing and packaging including serialization.
  • Experience across biologics and small molecules, your adaptability will be essential to your success.
  • A demonstrable track record of successful project management and execution in relation to tech transfer, you will be a skilled collaborator.
  • Global exposure to manufacturing, registering and distributing pharmaceuticals.
  • The ability to travel when required, most of our partners are based Europe.


What We Offer


  • Salary – from £60,000
  • Agile Working – we offer flexibility and trust from day one, you must be able to travel to our Egham office 2 days per week to attend key meetings, build relationships and immerse yourself in the business.
  • £150 towards your home office – claim purchases back on expenses.
  • Healthcare Insurance
  • Pension – you contribute 5% and we offer 3%.
  • Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
  • Enhanced Family Leave
  • Enhanced Sick Pay
  • Annual Leave – 26 days plus bank holidays, 3 days shut down between Christmas and NY.
  • Discretionary Annual Performance Bonus

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