Hobson Prior are seeking for an Analytical Validation Specialist to join a Biotech organisation to be located in London on a permanent basis. Our client are determined to develop treatments who can save patients' lives.
Please note that to be considered for this role you must have the right to work in this location.
Produce method SOPs are developed and executed to support all validated methods.
Partner with validation, QC, QA, and R&D team as well as with external partners to support internal and external project timelines.
The development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
Create validation test protocols and reports in support of the tech transfer and validation activities performed ensuring compliance requirements are maintained.
Support the setup of the QC department for the continuation of the clinical trial material, commercial supply, and stability studies.
Confirm appropriate communication to method transfer progress and plan adherence.
Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
Ensure the development and rollout of training on new technology/methodology.
Complete routine assessment of the analytical methods used to assure they are being applied and are operating as expected.
Confirm all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
Confirm all training is commenced in a timely manner as required to perform required activities. Support any training activities of other employees where required.
Support with continuing with QMS and controlling of documents and ensuring the data integrity of all data produced.
Ensure own work complies with GMP, Data Integrity, and Good Documentation Practice and is undertaken in accordance with applicable quality documents e.g. SOP's, Protocols, Guidance's, etc.
Ensure own training is completed in a timely and GMP compliant manner before the task is undertaken.
Confirm own KPI's, plans, targets, and objectives are effectively tracked, monitored, and achieved in agreement with timelines.Requirements:
Educated in a MSc in Biosciences or Biochemistry with equivalent relevant work experience in the pharmaceutical or other similar regulated industry.
Previous experience in an analytical development and validation role in the pharmaceutical industry with a strong research background.
Previous experienced with analytical techniques, example, qPCR, HPLC, ELISA, SDS, cell-culture and DNA extraction, including method development and troubleshooting.
Expertise in a body of information required for the job e.g knowledge of EU and FDA regulations, ICH guidelines, GMP/GLC/GCP, 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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