Vall d’Hebron Institute of Oncology (VHIO) seeks a “Clean Room – ATMPs Process Development and Production Responsible”.
Reference: 2024-075-01
Application deadline: Until position filled
Number of vacancies: 1
Job description:
Reporting to the Clean Room – Advanced Therapies Medicinal Products (ATMPs) Qualified Person (QP) the mission of the role will be to ensure the compliance with Good Manufacturing Practices (GMP) associated of ATMP process development and manufacturing operations.
Duties:
In general, ensures that the process development of novel ATMP as well as their manufacturing is conducted in accordance with approved Specifications and Manufacturing Guidelines for each ATMP. Additionally, ensures that appropriate validations are performed regarding new and existing processes in accordance with GMP conditions and other production operations. ATMPs Process Development and Production Responsible will closely interact with translational/preclinical researchers from VHIO and external entities to translate research products into large-scale manufacturing processes compliant with GMP regulations.
- Develop and maintain Manufacturing Guidelines according to approved requirements in drug regulatory documentation (IMPD or CTD), specifications, or other documentation.
- Design, develop, and implement SOPs and specific records for the Production Area, including authorized requirements, and ensure their implementation within the Quality System.
- Participate in the design, development, and execution of validations related to manufacturing processes and/or quality controls, both for existing and novel processes.
- Optimize specific steps of existing approved manufacturing processes in order to design more efficient and automatized manufacturing processes.
- Collaborate in designing, executing, and enforcing Biosecurity guidelines to ensure compliance with environmental control measures for confined use of Gene Therapy Medicines (including Combined Gene Therapy Medicines), associated with handling, equipment, and facilities.
- Collaborate and participate in technology transfer activities (production processes) with external entities, if necessary.
- Coordinate production activities performed in the clean room and ensure coordination within the implemented Quality System.
- Review all completed forms for each manufactured batch, issue documented batch assessment, and deliver to the Quality Control Responsible.
- Complete and record ATMP batch data in Manufacturing Guidelines and other records, including SOP-related records.
- Document any non-conformity, change, or identified risk in their area of responsibility and participate in its management and follow-up, both during process development and manufacturing.
Requirements:
- Master or Bachelor’s degree in the biosciences field.
- Experience in cell culture techniques, viral vector handling, tissue manipulation, and biotechnological techniques.
- Experience in T-cell based ATMP such as TIL, PBL, CAR-T and TCR.
- Background in preclinical-basic research with a focus on immunology and/or immunotherapy preferred.
- Knowledge of specific characteristics of advanced therapy medicinal products (cellular and gene therapies), including cell and tissue biology, biotechnological techniques, and analytical techniques for characterization of advanced therapy medicinal products (cellular and gene therapies).
- Knowledge of GMP guidelines specific for ATMPs.
- Knowledge of cell therapy platforms to develop new processes maximizing closed system steps and automated equipment.
- Experience working in controlled conditions or in cell culture laboratories (clean rooms or similar environments).
- High organizational skills for multi-stakeholders’ projects.
Additional information:
What we offer:
- 📈The opportunity to develop your professional career in a competitive environment.
- 🧠To be part of a center that is in constant development, seeking excellence in research and collaborating with leading teams.
- 🫱🏻🫲🏾We offer and promote a diverse and inclusive environment, and welcome all people equally, regardless of age, disability, gender, nationality, race, religion or sexual orientation.
- ✨VHIO has been awarded the HR Excellence in Research Badge (link a la sección) that identifies the institutions and organisations as providers and supporters of a stimulating and favourable working environment for Research.
- 🪴We care about our environment and understand the importance of sustainability. We have the GreenVhio program, which you can be a part of.
Working conditions:
- 📝Permanent contract.
- 🍉Fresh fruit every tuesday.
- 💶Salary according to qualifications and experience following VHIO pay scales.
- 💳Flexible remuneration program (includes restaurant vouchers/cards, transport, medical insurance, and “baby daycare” voucher).
- ⏰Flexible working hours and measures to balance work, family, and personal life, and promote gender equality, as established in the VHIO collective agreement.
- 🗺️23 days of holidays and 5 personal days.
- 🎓Fully subsidized Catalan, Spanish, or English courses.
Application:
Potential candidates should submit a curriculum vitae, letter of intent, to selecciorrhh@vhio.net including the reference “Ref. 2024-075-01” in the subject line of your email.
About VHIO:
Under the leadership of Josep Tabernero, the Vall d’Hebron Institute of Oncology (VHIO), has established itself as a comprehensive cancer center of proven excellence internationally. It is also thanks to VHIO’s optimal organizational structure based on a purely multidisciplinary and translational model that VHIO talents continue to anticipate and tackle the many unresolved questions in combatting this multifaceted and heterogeneous disease.
Located within the Vall d’Hebron Barcelona Hospital Campus, our researchers closely collaborate and interact with Vall d’Hebron physician-scientists. Translational science and clinical research are therefore tightly connected which promotes superb interaction and teamwork which, in turn, accelerates the bench-bedside-bed cycle of knowledge. This privileged environment affords VHIO direct access to patients as well as the entire spectrum of oncology professionals who care for them, and a second-to-none appreciation of how cancer science can translate into more powerful, targeted treatments and better practice for the care of patients.
VHIO’s pioneering model and programs, coupled with its belief in combining strengths through cross-border collaborations, continue to spur advances in reversing cancer resistance, halting metastatic spread, and more effectively treating even the most undruggable tumor types.
VHIO’s translation toward precision oncology: https://www.vhio.net
Vall d’Hebron Institute Oncology (VHIO) endorses the Requirements and Principles of the European Charter for Researchers, the Code of Conduct for the Recruitment of Researchers promoted by the European Commission and follows Equal Opportunities policies.
On 10th April 2018 VHIO was awarded the “HR Excellence in Research” logo. Our Institute was consequently granted permission to use the HR Excellence in Research Award logo as demonstration of its stimulating and favourable work environment in line with the Charter & Code
