Quality Control Scientist

An international biotechnology company is recruiting a Quality Control to their UK office. The organisation focuses on gene therapy to treat the suffering of people suffering from chronic systemic diseases. With a next-generation gene therapy platform to provide treatments for a wide range of diseases, this position represents an exciting opportunity to work with a leading company.

Job Responsibilities:

• Supporting the QC manager in establishing a GMP/GCLP compliant QC lab to support the release and stability testing of AAV products manufactured at the GMP facility.
• Testing pre and post clinical samples as part of our clinical trial programmes.
• Transferring technology and validating in-process and release assays from the company's Development lab into the new QC lab.
• Executing analytical testing programmes as directed by the QC Manager, according to GXP, with defined schedules and responsibilities.
• Supporting the GMP manufacturing team with environmental monitoring and raw material release.
• Following SOPs and Protocols, effective performance of analytical methods generating valid and reliable data.
• Recording accurate and compliant data and reporting of all data per SOPs, including peer review checking.
• Running routine maintenance, verification, and qualification of specified analytical systems to include PCR and plate reader systems.
• Interacting with quality professionals and responding to audit findings as required by the QC Manager.
• Presenting data at Project Team meetings.
• Participating in analytical and OOS investigations when required, within a culture of continuous improvement, and notifying of unusual observations, errors/unexpected findings to management.
• Contributing to analytical methods development.
• Participating in training and development programs as required.
• Complying with Health and Safety legislation and company policies, identifying potential hazards in the workplace.
• Maintaining close working relationship our development lab.

Skills and Requirements:

• Degree level education.
• At least 5 years of experience in the Analytical Sciences gained during development of Biotechnology/Biopharmaceuticals/Vaccines, either in industry and/or research.
• Significant experience in Biological assays in a variety of applications to include establishing and validating:

• RT-PCR methods
• Cell based assays
• Experience aspetic cell culture techniques

• Experience in working in a GMP/GCP environment and working wih quality professionals
• Contribution to reporting of data, generation of certificates, protocols, SOPs and internal written reports.
• Experience of working within a QMS to include change control systems, deviations and OOS reporting.
• Experience of analytical testing in a regulated environment.
• Understanding of a GMP manufacturing environment.
• Experience of GXP documentation requirements for Quality Control and bioanalysis, with an emphasis on data integrity, sample traceability and ensuring confidentiality at all times.
• Understand elements of risk management to help lead on decisions.
• Higher degree in a relevant discipline.
• Expertise in analytical development.
• Experience of analytical process science, and/or formulation science for viral gene therapy products.
• Experience of pre-clinical and early stage clinical development.
• Professional qualifications with independent recognition by learned societies.

• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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