We are currently recruiting for an experienced QC Manager to join my client based in Sevilla on a permanent basis. Within this role you will work with a team working with Cell and Gene therapy, Focusing on Natural power of body to cure disease. As the Quality Control Manager, you will lead the Analytical development as well as Quality Control Activities by supporting Phase 3 Clinical trials of lead product.
· Management and maintenance of the QC laboratory including calibration and qualification of analytical instruments, oversight of our quality control systems and analytical testing program.
· Coordinating (including tech transfer) QC activities when manufacturing is outsourced to CMOs.
· Approving and reviewing technical and GMP documents (analytical protocols, reports, SOPs, specifications.
· Supporting OOS investigations and other non-conforming results and proposing/implementing corrective/preventive actions.
· Coordination with the Manufacturing and Quality Assurance teams (Spain and France) to resolve quality issues about the facilities, products manufacturing and process development.
- Development and implementation of product characterization plan for cell therapy products (bone marrow, mesenchymal and other stem cells) in cardiovascular, neurological and other diseases.
- ? Development, optimization, standardization and validation of methodologies for characterization of cellular therapies and evaluating new technologies as required.
- ? Cellular characterization of raw material, in process and final product based on protein and RNA expression and cellular morphology.
- ? Documentation of characterization and methodologies to support EMA, FDA and other regulatory filings.
· A Bachelor\'s degree in a biological science (e.g., molecular biology) with a minimum of 5 years? experience in a GMP environment or Master?s degree with a minimum of 2 years? experience in a GMP environment.
· Experience in ATMPs, Cell and Gene Therapy industries is an advantage.
· Strong experience in assay development.
· Expertise in flow cytometry is essential.
· 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 (experience in statistical software packages e.g., SAS, JMP would be an advantage).
· Ability to manage and lead a team of experienced scientists.
· Excellent communication and listening skills.
· Basic knowledge of regulatory guidelines concerning analytical development/validation.
· Good technical and IT skills.
· Fluent in both English and Spanish.
For further details, please contact Driss Kholti on +44(0)1727 817 615 or email a copy of your CV to email@example.com
- Agency: Achieva Group Limited
- Contact: Tim Barratt
- Phone: 01727811634
- Reference: BH-25526
Website: Achieva Group Limited
- Updated: 15th April 2021
- Expires: 13th May 2021