Qc Tech Transfer Specialist

Hobson Prior are currently seeking for a QC Tech Transfer Specialist to join a brilliant biotech organisation on a permanent basis located in London. Our client is focused on producing solutions that might possibly cure people who suffer from severe illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will be accountable for transferring assays from MSAT to QC labs in both company sites for the testing of gene therapy products and affiliated resources used for manufacturing to EU and FDA GMP needs.
• Guide within the introduction and development of nee analytical strategy for testing gene therapy products.
• Form and uphold efficient cooperation and communication with MSAT, QC validation and QC Analytics staff in both company locations.
• Responsible for preparing both scientific and technical documentation, guaranteeing that work complies with GMP, data integrity and GDP.
• Conduct new analytical processes under the leadership of strategy developers and transfer the expertise obtained to written protocols.
• Collaborate with the QC Tech Transfer team to prepare the strategy used within the QC labs.
• Produce and adhere to project plans to assure that assays are transferred within the necessary timelines.
• Guarantee that the strategy is suitable for use within a GMP QC setting, forming suitable controls and assessment criteria for system suitability parameters.
• Any other assigned duties.

Requirements:

• Educate to an advanced degree level in a scientific field.
• Familiarity and comprehension of a variety of analytical practices, which involves HPLC, qPCR, CE, ELIZA, cell culture, etc.
• Acquaintance within analytical development/Tech Transfer of assays.
• Know-how of a GMP setting and quality control in a pharmaceutical or any other regulated organisation.
• Comprehension of GMP needs, for example: legislation, regulations and needs linked to Gene Therapy, QC analytical method transfer, and qualification would be advantageous.
• Competent with a body of information needed for the job, such as knowledge of EU and FDA guidelines, GMP/GLP/GCP, lean manufacturing, six-sigma, etc.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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