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Ixaka

Deputy Quality Control Manager

Seville, Andalusia, ES
FULL TIME

Company: Ixaka

Category: Production Occupations

Published on 2022-05-12 06:25

Ixaka is a private UK-based cell and gene therapy company with operations in the UK, Spain, and France. The company is focused on the natural power of the body to cure disease.

Our proprietary technologies enhance the inherent therapeutic power of cells by targeting curative cells to the site of disease and by directly modifying cells within the body to improve their therapeutic action.

Ixaka’s technologies – concentrated multi-cell therapies and targeted nano-particles –demonstrate potential for the treatment of a broad range of serious diseases across oncology, cardiovascular, neurological and ocular diseases, as well as genetic disorders.

Ixaka is now recruiting a Deputy QC manager to support the QC Manager in the day to day running of the function for our ongoing Phase 3 Clinical of lead product REX001, ensuring compliance with ATMP specifications and adherence to GMP standards, whilst supporting the overall quality and business strategy. The position will report into the QC manager.

The position will be based in Sevilla, Spain.

 

Requirements:

 

·        Bachelor's degree in pharmaceutical or biomedical science.

·        At least two-year experience working in Quality Control laboratory under GMP conditions in the pharmaceutical industry.

·        Master´s degree in pharmaceutical or biomedical science is an advantage.

·        Experience in ATMPs, Cell and Gene Therapy industries is an advantage.

·        Expertise in flow cytometry is an advantage.

·        Strong attention to detail, observation, organizational, and leadership skills.

·        In-depth knowledge of quality control procedures and legal standards.

·        Strong knowledge of data analysis and statistical methods.

·        Excellent communication and listening skills.

·        Good written and speaking proficiency in English.

·        Good technical and IT skills.


Responsibilities:

 

·        Deputy QC manager, with responsibility for approval of cellular therapy products for use in clinical trials or other clinical applications when necessary.

·        Testing of patient-specific cell therapy product batches in phase 3 clinical trial for release for administration under GMP standards, using techniques such as flow cytometry, endotoxin determination, gram stain and ELISA.

·        Standardization, validation, and implementation of methodologies for characterization of cellular therapies.

·        Sampling and inspection of starting material, final product, raw materials and labels.

·        Setting requirements for raw materials from suppliers and monitoring their compliance.

·        Determination and definition of limits for product quality and specification of final product including justification and documentation for regulatory filings.

·        Preparation of procedures, SOPs and experimental results under GMP standards.

·        Performing investigations and writing deviation reports. Management of OOS/OOT.



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