QC Scientist - Third Party Manufacturing

Gyroscope ,
London, Greater London
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Job Description

JOIN OUR VISIONARY TEAM AS OUR NEW QC SCIENTIST - THIRD PARTY MANUFACTURING We discover, develop and deliver innovative medicines to preserve people's sight and fight the devastating impact of blindness around the world. OUR PROMISE TO PATIENTS - IS BIG Gyroscope was created to bring the right people and resources together to fundamentally change the lives of patients suffering from retinal diseases. We know that our people, with their passion for patients, will drive to deliver on this promise. Our ultimate goal for our patients is Vision For Life and you will be a vital contributor. Position summary: Gyroscope's analytical development and QC team is responsible for developing state of the art methods for the analysis of the company's increasing portfolio of gene therapy medicines and ensuring these methods are appropriately implemented for QC release testing. A highly motivated individual is sought to deliver Quality Control aspects within this team. The successful candidate will be expected to lead and facilitate analytical validation and QC testing work carried out by contractors and to work with internal groups to help develop and maintain capability and business processes to meet the requirements of these products under the supervision of the Director Quality Control and CMC Analytical Development. This role will give the successful candidate the opportunity to join a rapidly growing world-class team and to play a part in shaping the growth of this exciting biotechnology company. Experience in Pharmaceutical Quality Control is expected including working knowledge of analytical techniques such as qPCR/ddPCR, immunoassays, cell-based assays, capillary electrophoresis. While not essential, expertise in in gene therapy development or validation of compendial safety assays for biopharmaceutical products will be a considerable advantage. Specific requirements include: * Development and maintenance of data and systems required to progress the analytical life cycle from development to commercialisation * Author or review methods and develop method qualification/validation project plans and strategies * Technical review of analytical tech transfer documentation (primarily within or between external contractors) * Interface with method development team members to ensure delivery of analytical development / qualification documentation that is fit for purpose of the stage of product development * Contribute to product specification development and ensure alignment with process/method capabilities * Provide data and commentary for regulatory submission and provide technical and accuracy review on new submissions * Author and review of relevant analytical sections of regulatory dossiers * Work with outside testing laboratories, contract manufacturers and other vendors, including support for audits/assessments and shaping/delivering remediation programmes as required * Develop QC standards and procedures as required and implement any necessary changes to keep in compliance with applicable regulations and guidelines and best practice * Participate in the investigation or review of change controls, quality deviations and OOS/atypical results generated at third parties * Review and interpretation of analytical data to ensure validity and compliance with procedures / standards * Participate in periodic assay reviews to ensure consistent performance, compliance with cGMP and continued delivery * Track third party analytical data and ensure testing is carried out to agreed schedules and quality requirements including data integrity. Education / Qualifications: * Scientific degree (Biochemistry, Chemistry, Biology, Molecular Biology, Biomedical Sciences etc.) * 5+ years of relevant industry experience * In-depth experience in executing QC assays under GMP conditions with one or more of the following techniques: qPCR/ddPCR, immunoassays, cell-based assays, capillary electrophoresis * Practical experience of analytical validation and tech transfer * Working knowledge of Quality Management Systems as applied in GMP QC labs, such as data management, audit activities, change control, CAPA, LIR, OOS investigations * Excellent communication, organisation, and presentation skills - both written and oral skills * Able to work effectively in collaborative team environment where results are achieved through the incorporation of multiple points of view * Independently motivated, detail-oriented and good problem-solving ability Preferred qualifications: * Experience in gene therapy analytical development or QC testing * Working knowledge of compendial test requirements for biopharmaceutical products * Participation in GMP audits of QC areas as Subject Matter Expert Apply for this Job

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