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Analytical services (as) scientist

Bristol (City of Bristol)
Scientist
Posted: 19h ago
Offer description

Job title: Analytical Services (AS) Scientist Reporting to: Senior AS Scientist Department: Analytical Services No of Direct reports: 0 Location: Bristol Summary: eXmoor Pharma is the only integrated cell and gene therapy CDMO with over 20 years of consultancy expertise embedded across every stage of the CMC journey — from early-phase strategy to process development, GMP manufacturing and commercialisation. We provide comprehensive support across Viral Vectors, Autologous and Allogeneic Cell Therapies, and RNA technologies. This integrated model enables seamless progression from early-phase strategy through to commercial readiness. This is an exciting opportunity to work with eXmoor’s globally recognised team of scientists, consultants and engineers. You will work on a wide range of Client projects in a rapidly growing business whilst developing your quality management career. ​ Job Description: ​ Job Purpose: The GMP manufacturing facility is capable of handling a wide range of cell and gene therapies as well as small scale complex biologics. The facility covers two technical areas (Process Development (PD) & GMP clinical phase production with an Analytical Services team supporting both Development and GMP), both working closely together such that processes developed in the PD area will be transferred at scale to the GMP suites. The AS Scientist will be responsible for conducting analytical assays in support of manufacturing and product release. The AS Scientist will also be responsible for supporting the development of methods and performing testing of process development samples in support of PD projects. The AS Scientist will be involved in the execution of validation protocols and collation of data to support method establishment for GMP programmes. Main areas of responsibility / key duties: Testing: You will run assays according to approved procedures and reporting of data You will maintain and calibrate the analytical equipment You will prepare buffers to be used in assays You will prepare reference standards You will be responsible for receipt, labelling and storage of samples You will qualify assays and reference standards You will perform routine environmental monitoring in cleanrooms You will prepare samples for shipment You will release raw materials Analytical Services Laboratory: You will support the AS team in maintaining the laboratory area including maintaining stock levels and area cleaning You will order consumables and reagents ​ You will supervise engineers during maintenance / calibration visits Documentation: You will be responsible for drafting SOPs and forms for the conduct of assays Training: You will be responsible for maintaining your training Safety: You will conduct your duties to the highest quality standard and in a safe way complying with all policies and procedures and with due care and attention for yourself and your peers. You will comply with GMP and laboratory documentation including risk assessments, SOPs, COSHH forms, lab notebooks and records. ​ Person Specification: Essential Qualifications & Experience: Minimum BSc degree level in relevant subject area or equivalent experience Experience (>1 year) of working in a regulated and controlled laboratory area Experience in analytical procedures such as HPLC, FACS, qPCR, ELISA (experience in all not an absolute) Ability to report data accurately and completely Experience in following approved procedures Understanding of GMP and working with in an analytical function Desirable Qualifications & Experience: Development of analytical methods Writing analytical procedures Experience of working within a QMS and raising deviations, OOS reports etc. Competences Required: ​ Organisation, planning and time management Oral and written communication skills Strong team worker Innovation, inquisitiveness, and willingness to learn Attention to detail and getting things finished Problem solving Proficiency in Office365 (including Word, Excel, PowerPoint).

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