Meridian Life Science / Bioline develops, manufactures, and markets a wide range of specialized bio-research reagents that simplify, accelerate, and improve life sciences research.

The successful candidate will work as part of the QA/RA team with full responsibility of MLS Molecular validation program, including validation of processes, analytical assays for new Meridian products, improving existing methods, developing new assays for legacy products, validating equipment and software, examination/assessment of product stability, troubleshooting and undertaking projects in conjunction with other departments, in the first instance R&D, production and operations. Part of the role will involve support of the QC department during busy times. The role is laboratory based with significant amount of paperwork.

• Responsibility for the Meridian Life Science Validation program at both sides (UK and Germany).
• Validation of analytical assays for new and legacy products.
• Support of QC transfer, development and re-development of QC assays.
• Preparation, performing experimental assays for initial transfer testing, formal validations, and documentation of the results.
• Validation and risk assessments of production processes.
• Validation, verification and revalidations of equipment.
• Validation of software.
• Validation of non-verifiable processes and support of process validation in general.
• Maintenance of the validation master plans.
• Ensuring compliance of validation processes with ISO 13485
• Executing and maintaining the internal equipment calibration and verification program
• Taking responsibility for the long-term stability programs of Meridian products.
• Analysis, review, optimization and development of analytical assays for molecular biology products including documentation, establishing analytical procedures and training.
• Supporting the quality control team in all aspects, this includes support during high workload, perform special testing and troubleshooting.
• Taking a risk-based approach according to ISO 13485.
• Assuring that all documents required by Meridian’s QM System related to assay development and validation are prepared in a timely manner in accordance with agreed priorities and plans.
• Assisting in the investigation and completion of Non-Conformance reports and CAPA improvements.
• Supporting the continual improvement process.
• Managing a team of scientists.
• Advanced knowledge in validation and validation standards and/or guidelines for assays, processes, equipment and software.
• Deep understanding, hand on experience and background of all kinds of qPCR and isothermal amplification assays, including assay development, optimization, data analysis and interpretation.
• Deep understanding, hand on experience and background in end point PCR, practical enzymology, biochemical assays, and molecular biology techniques (DNA/RNA extraction, reverse transcription, primer/probe design, nucleic acid and protein quantification).
• Profound knowledge of analytical methods, including practical enzymology, biochemical assays, spectroscopy/spectrophotometry, chromatography, and electrophoresis and practical experience of the same.
• Good regulatory knowledge of standards like ISO 13485, and awareness of requirements set out in ISO 13485 related to assay, process, equipment and software validation and the required documentation. Ensure compliance of mentioned processes with other articles of ISO 13485 where required.
• Knowledge on risk-based approaches within ISO 13485.

• MSc, PhD or equivalent in life science
• 5-7 years of experience preferable in relevant industry
• Ability for autonomously develop, optimize and validate analytical assays using qPCR, PCR, spectrophotometry, chromatography and molecular biology techniques.
• Advanced skills in troubleshooting problematic assays.
• Good command of common statistical analysis.
• Advanced technical writing skills, including creation of protocols, validation plans, SOPs and regulatory documents.
• Excellent cross-functional communication skills, allowing to collaborate with the different departments.
• Excellent project management skills, including organization, planning, execution, risk assessment and risk mitigation.
• Leadership: Must be able to mentor a team of scientist.
• Critical thinking: Making informed decisions based on data and scientific rationale
• Adaptability: Must be able to prioritize, organize workloads and meet task deadlines.
• Ability to interact effectively with an interdisciplinary group on various levels.
• Excellent communication skills and very good knowledge of written and spoken English.
• Good strategic thinking and attention to detail, aligning validation activities with company goals and regulatory requirements.