Manufacturing Manager of VHIOâs clean room (VHIO)
Manufacturing Manager of VHIOâs clean room (VHIO)
Posted on :
22-05-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
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.
Education and qualifications:
Required:
- Master or Bachelors degree in the biosciences field
- Fluency in Catalan Spanish English (business level)
Experience and knowledge:
Required:
- Experience in cell culture techniques viral vector handling tissue manipulation and biotechnological techniques.
- Experience in Tcell based ATMP such as TIL PBL CART and TCR.
- Background in preclinicalbasic 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).
Desired:
- 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 multistakeholders projects.
Main responsibilities and 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 Manufacturing Manager will closely interact with translational/preclinical researchers from VHIO and external entities to translate research products into largescale 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 SOPrelated records.
- Document any nonconformity change or identified risk in their area of responsibility and participate in its management and followup both during process development and manufacturing.
Labour conditions:
- Fulltime position: 40h/week.
- Starting date: immediate.
- Gross annual salary:euros /// (Salary ranges are consistent with our Collective Agreement pay scale).
- Contract: Technical and scientific activities contract linked to the project
What can we offer
- Incorporation to Vall dHebron Research Institute (VHIR) a public sector institution that promotes and develops the biomedical research innovation and teaching at Vall dHebron University Hospital (HUVH) the biggest hospital of Barcelona and the largest of Catalan Institute of Health (ICS).
- A scientific environment of excellence highly dynamic where highend biomedical projects are continuously developed.
- Continuous learning and a wide range of responsibilities within a stimulating work environment.
- Individual training opportunities.
- Flexible working hours.
- 23 days of holidays 9 personal days.
- Flexible Remuneration Program (including dining checks health insurance transportation and more)
- Corporate Benefits: platform through which you can obtain significant discounts on travel culture technology gastronomy sports... among many others.
- Healthy Offering: choose from a variety of wellbeing focused activities to be the healthiest you.
Deadline to apply:
VHIR embraces Equality and Diversity. As reflected in our values we work toward ensuring inclusion and equal opportunity in recruitment hiring training and management for all staff within the organization regardless of gender civil status family status sexual orientation gender identity and expression religion age functional diversity or ethnicity.
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
