mRNA Manufacturing Scientist in Alnwick

The Role This role is central to translating Arcinova’s mRNA manufacturing capability into a robust, repeatable, and client-ready service offering. By combining scientific understanding with disciplined GMP execution, the Manufacturing Scientist will help deliver high-quality mRNA drug substance and formulated bulk drug product for vaccine and therapeutic development programmes. Main Responsibilities Operate biofoundry-enabled, automated, modular, or continuous flow systems used for IVT, purification, formulation, and process intensification activities. Support process set-up, parameter verification, in-process sampling, process monitoring, and escalation of alarms, deviations, or unexpected trends. Contribute to the development of robust and repeatable workflows that support efficient transition from development-scale to GMP manufacture. Support technology transfer of client processes, internal platform processes, and new mRNA manufacturing workflows into the Arcinova manufacturing environment. Assist with process development, engineering runs, manufacturing readiness activities, material readiness, equipment readiness, and campaign planning. Provide practical manufacturing input into batch records, SOPs, risk assessments, process descriptions, sampling plans, and manufacturing instructions. Complete GMP documentation accurately, contemporaneously, and in accordance with data integrity expectations. Identify, report, and support investigation of deviations, non-conformances, process issues, and equipment events. Work in accordance with GMP, health and safety requirements, biosafety expectations, cleaning procedures, Grade C cleanroom gowning requirements, aseptic behaviors, and site quality systems. Work collaboratively with Analytical Development, Quality Assurance, Quality Control, Validation, and Supply Chain to deliver client projects. Support continuous improvement of mRNA manufacturing processes, documentation, equipment set-up, training materials, and operational ways of working. Maintain training compliance and contribute to a positive, safety-conscious, quality-focused manufacturing culture. Flex responsibilities, where required by business need, to support small molecule drug product manufacturing activities while maintaining appropriate training, GMP compliance, and quality standards. Operate, monitor and clean mRNA manufacturing equipment and single-use systems within a Grade C cleanroom, following approved procedures and batch records. Perform mRNA manufacturing activities, including in-vitro transcription, reaction monitoring, purification, concentration, buffer exchange and sterile filtration. Support mRNA formulation activities, including material preparation, controlled mixing, sampling, TFF and transfer to downstream operations. Operate automated, biofoundry-enabled and continuous flow manufacturing systems for IVT, purification and formulation processes. Support process setup, parameter checks, in-process sampling and performance monitoring, escalating issues where required. Contribute to developing robust, scalable workflows for GMP manufacturing. Support technology transfer of client, platform and new mRNA manufacturing processes into the Arcinova manufacturing environment. Assist with process development, engineering runs, manufacturing readiness and campaign planning activities. Contribute to batch records, SOPs, risk assessments, sampling plans and manufacturing instructions. Complete GMP documentation accurately and in line with data integrity requirements. Identify, report and support investigations into deviations, non-conformances and equipment or process issues. Adhere to GMP, health and safety, biosafety, cleanroom and site quality requirements. Collaborate with cross-functional teams, including Analytical Development, QA, QC, Validation and Supply Chain, to deliver client projects. Support continuous improvement of manufacturing processes, documentation, equipment setup and training materials. Maintain training compliance and promote a safe, quality-focused manufacturing culture. Provide flexible support across manufacturing operations as business needs require, while maintaining GMP and quality standards. Experience Required Degree, higher degree, or equivalent experience in Molecular Biology, Biochemistry, Biotechnology, Bioprocessing, Pharmaceutical Sciences, or a related discipline. Working knowledge of GMP, documentation control, deviation management, change control, training compliance, and data integrity. Ability to follow manufacturing instructions, complete batch records accurately, and work in line with SOPs and quality standards. Strong communication, organisation, problem-solving, and teamwork skills. Scientifically curious and motivated to help establish a new mRNA manufacturing capability. High attention to detail, a willingness to learn, and the ability to work effectively in controlled manufacturing and Grade C cleanroom environments. Delivery-focused with the ability to follow procedures, identify improvement opportunities, and support safe, compliant operations. Experience in mRNA, RNA or nucleic acid manufacturing, including areas such as in-vitro transcription, purification, filtration, chromatography, TFF, or formulation. Experience operating automated, closed, modular, continuous flow, microfluidic, or biofoundry-enabled manufacturing systems. Experience supporting technology transfer, process development, clinical manufacturing, engineering batches, or CDMO projects. Familiarity with Grade C cleanrooms, aseptic techniques, single-use systems, process equipment, qualification activities, cleaning verification, or environmental monitoring.