Supply Chain Manager - Biologics Development



North Wales, United Kingdom 


GBP 40000.00 - 50000.00

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We are currently looking for a Supply Chain Manager to work within the Biologics Development team at a leading biopharmaceutical company based in Wrexham. As the Supply Chain Manager - Biologics Development you will be responsible for managing the supply chain for early stage product development as part of Biologics Development (CMC) and also within Clinical Trials, supporting effective new product development, testing and supply for Toxins and other Biological products developed and in-licensed.KEY DUTIES AND RESPONSIBILITIES:Your duties as the Supply Chain Manager will be varied however the key duties and responsibilities are as follows:1. Co-ordinate and manage all aspects of early product supply chain; from production to fill-finish and testing, release and delivery to pre-clinical (pharmacology/toxicology) and clinical development sites, transfers to Manufacturing/QC and internal/external partners.2. Implementation of pro-active & effective product scheduling and delivery strategies to meet development timelines and requirements in co-ordination with: Biologics Development operations, CMC Project Managers and Sponsors, Clinical supply groups, Commercial/Global supply chain support, Development Fill sites, Production/Labelling managers, Quality & QP Release managers, CRO scheduling and Customer service co-ordinators.3. Manage appropriate development & lifecycle strategies for material supply in compliance with ICH, Pharmacopeia and cGMP requirements, providing regulatory documentation to support product development plans to first time regulatory approvals: Including input to Tox & Clinical protocols, Regulatory agency briefing documents, IMPD/INDs, meeting effective pre-clinical and clinical development study requirements in co-ordination with in-house operations and third party contractors.4. Provide comprehensive understanding of project planning strategies, data management and regulatory requirements for biological product development supply.ROLE REQUIREMENTS:To be successful in your application to this exciting opportunity as the Supply Chain Manager - Biologics Development we are looking to identify the following on your profile and past history:1. Relevant degree in a Life Science discipline such as Biochemistry, Biotechnology or similar, as well as extensive industry experience.2. Proven industry experience in biologics development and project management from a clinical trials background. 3. A working knowledge and practical experience with supporting regulatory submissions for FDA, MHRA etc.Key Words: Supply Chain | Clinical Trials | Biologics | GMP | Biopharmaceuticals | Project Manager | Manager | Pharmaceuticals | CRO | CMO | Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves
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Swindon, Wiltshire, United Kingdom

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