QC Senior Technologist (Method Transfer)
My client is a fast-growing biopharmaceuticals company based in the South-West of England.
Experts in developmental production and the bringing to market of biologicals, my client have decades of experience in production, characterisation, process and analytical validation of life saving biopharmaceuticals, including the Anthrax Vaccine.
Taking on the mantle of QC Senior technologist will see you reporting directly to the QC Analytical Manager.
You will be tasked to manage and perform the transfer/validation of analytical methods from Development into a GMP environment in QC Analytical Services (QCAS). The role involves all activities involved in transferring analytical methods from Development to QCAS, including running analytical methods in both Development and QCAS, writing transfer/validation protocols, executing protocols in the laboratory, writing up the associated transfer/validation reports, performing release analysis and training existing members of staff in transferred methods.
• Utilising technical skills to validate specialised chemical and biochemical tests procedures to internationally recognised regulatory guidelines. Conduct problem solving investigations to resolve issues affecting Pharmaceutical manufacture.
• Use technical expertise to be trained in and become a subject matter expert in methods being transferred.
• Manage all activities involved in transferring analytical methods from Development to QC Analytical Services including running analytical methods in both Development and QC Analytical Services, writing transfer/validation protocols, executing protocols in the laboratory, writing up the associated transfer/validation reports and performing release analysis.
• Perform release and stability testing of transferred methods.
• Train out analytical methods within a GMP environment.
• Work with project teams and represent QC on these to contribute to the success of these business centres by delivering the required Analytical knowledge and services.
• Play a lead role with both internal and external customers.
• Maintain an up to date awareness of regulatory and scientific developments via approved training courses and meetings that will contribute to the efficiency and effectiveness of laboratory working practices and aid personal development.
• Authorship and review of SOPs, Protocols and Risk Assessments.
• Involvement in audits both from internal and external parties
• Write and review OOS investigations and deviation reports.
Salary is negotiable on experience
Are you prepared to begin a new chapter in your career? If so, this could be the role for you! For more information and a confidential discussion, please contact Kieran Whittaker on: -
Tel: - 0161 923 8174
Email: - Kieran.firstname.lastname@example.org