Senior Manager - Potency Assays (Analytical Sciences Division) in Liverpool - Pharmaron Biologics

Job Overview

Location
Liverpool, England
Job Type
Full Time
Salary
TBC
Date Posted
4 days ago

Additional Details

Job ID
43009691
Job Views
1

Job Description

UK - LiverpoolJob SpecificationWe offer:Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and excitingOpportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!Our Company: “We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving some of the most difficult scientific challenges”.We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.We are based in the vibrant city of Liverpool with a world class R&D and manufacturing facility that offers a complete end to end development service. Our 80,000 sq. ft facility houses an established Biologics Department that consists of Analytical and Process Sciences. Our Liverpool site has a remarkable 20 Year Track Record in Biologics Development, which now offer A Fully IntegratedGene Therapy Drug Substance Solution in our state of the art cGMP facility purpose designed for viral vectors with onsite plasmid DNA and renowned analytical capabilities for release and characterisationThe Pharmaron Liverpool Team has consistently delivered biologics programs across all development phases and due to exciting new developments, we are now recruiting for a Senior Manager – Potency Assays in our Analytical Sciences team.  This is a fantastic opportunity for you to be working in a state-of-the-art Gene Therapy facility, where you will be showcasing your Potency Assay skills and experience to advance our bioassay portfolio. You will have the opportunity to lead multiple projects, work on multiple product types and lead a strong, dynamic, committed team to timely deliver great science to our customers!We offer a world class working environment in our modern Liverpool siteWe offer a competitive salary and a progressive and comprehensive suite of employee benefitsWe offer the opportunity for growth and development and will support funding for relevant training and development programmesWe do more than manufacture batches, we develop medicines!Key roles and responsibilities:Leading the Cell and Analytical Molecular Biology team analytical CMC readiness activities by ensuring procedures, templates, specifications, and equipment and methods are timely developed appropriate and phase appropriately validated in line with quality procedures and regulatory guidelines.Setting objectives and giving performance feedback regularly throughout the year. Devising the training and development plan for the team. Ensuring all project work is delivered on time, to budget and to the required levels of technical quality, and that the team generates high quality outputs from experimental programmes, including presentation of results and technical reports.Building an effective team through continued development and through recruitment, retention and reward of scientific staff to ensure that Analytical Sciences is well equipped with scientific and technical competences to demonstrate excellence in the development of Client projects.Ensuring all work is undertaken to the required quality systems, where applicable to cGMP standards and always in compliance with the requirements of the Health and Safety Policy.Ensure the scientific studies and other technical activities are conducted and reported in line with regulatory guidance, executed to the right quality, time, budget and in compliance with HSE and Quality requirements.Reviewing and approving experimental programmes and documentation including but not limited to protocols, experimental write up, reports.Making proposals and implementing actions as part of the 5S, Operational Excellence and CAPEX programmes to drive technical and scientific excellence for improving quality, timelines and efficiencies within the team.QualificationRequirements:BSc/MSc (or equivalent) in a relevant life sciences field with biopharmaceutical or pharmaceutical experience.Significant experience within Potency Assays, including Infectivity Assays, Gene Expression Assays and Functionality AssaysSignificant experience in leading the design, development and delivery of analytical methods and associated phase appropriate method validation, transfer and understanding of cGMP release testing within the biotechnology industry.Understanding of analytical CMC development requirements for manufacturing drug substance, drug product and starting materials.Project management and setting clear objectives.Leading troubleshooting investigations and root cause analysis.Why Should You Apply?This is an opportunity for you as a Senior Manager to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition, and the desire to grow with the departmentBuild and shape your career in an environment that sets and commits to the highest standards of BiologicsTo be part of a team who support each other, embrace, and solve technical challenges and put excellence at the heart of all that we doFounded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 17,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

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