At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Technology Product & Platform ManagementJob Sub Function:
Technology Operations SupportJob Category:
Scientific/TechnologyAll Job Posting Locations:
Beerse, Antwerp, Belgium, Leiden, NetherlandsJob Description:
To be located in Belgium or the Netherlands
At Johnson & Johnson Innovative Medicine, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
Cancer immunology has rapidly progressed to one of the most promising forms of new treatments in which not the cancer, but the immune system is treated. This innovative and promising form of autologous cellular therapy provides real hope to patients in need. The CAR-T organization within Johnson&Johnson is working on a full pipeline with our most advanced candidate for the treatment of multiple myeloma being successful launched in multiple regions.
The Team
Excelling in science and technology, the Cell Science Team within MSAT AT works passionately to bring technological innovations to our patients. We are a fast-developing group and forward looking, working on improving technical processes, being patient focused and support the need for speed. This team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in a diverse and innovative environment.
The Role
The Technical Owner is overseeing the European apheresis and cryopreservation network as single point of contact for all technical aspects of technical operations at our most modern sites in the global network (internally and externally). In addition, the holder of the role is responsible for driving the implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products. Cross-functional partnership with R&D, Quality, and Manufacturing will be required to ensure processes meet the needs of today and tomorrow. Acting as the primary SME for cellular starting materials, overseeing both cryopreservation and apheresis processes, the Technical Owner will lead relationships with Operating Company level Cell Therapy teams during implementation of technical innovations. The successful candidate is therefore able to appropriately balance requirements with innovation and speed at cell processing sites as the team is driving multiple scientific and technical programs in a highly regulated environment. The capability to interact both with physicians and technical personnel at cell processing sites globally is essential for this role.
The ability to navigate within a global network and collaborate effectively with internal and external partners will be key to drive critical programs to successful completion. Up-to-date knowledge of industry standards and regulatory requirements related to cellular therapies are critical.
Main responsibilities
- Lead the local implementation of process changes
- Contribute to digitalization initiatives (such as MES integration, trend report-outs)
- Collaborate with European manufacturing sites resolving shared technical challenges and harmonizing processes across the sites
- Drive the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans relating to cellular starting materials
- Collaborate with R&D, site functions and finance to identify technical improvement or cost reduction opportunities
- Lead innovation opportunities, build project business cases and prioritize projects (starting material-related)
- Provide cryopreservation process training to operators to ensure global process consistency and retain knowledge within the CPC
- Proactively monitor apheresis and cryopreservation processes and performance to detect trends and develop mitigation plans
- Perform technical assessments for non-conformances related to starting materials and support failure investigations (incl. escalation of quality or compliance events)
- Present to health authorities during inspections
- Maintain a robust technical support network related to cell sciences, new technologies, automation, change management and tech transfers
- Identify and oversee implementation (in partnership with R&D) of lifecycle management, new technology and process improvement projects in our global cryopreservation network to improve robustness, scalability and cycle time performance
- Author and review technical reports, source documentation
- Create, maintain, and upgrade cellular starting material knowledge as an element of the value chain knowledge infrastructure
Qualifications:
- A Master’s or Ph.D. degree, preferably in a biological or biomedical technical discipline is required.
- A minimum of 7 years of experience in a pharma environment is required
- In-depth knowledge of the apheresis and cryopreservation processes is absolutely critical
- Working knowledge of cGMP and the EU Tissue and Cell Directives is required
- Project Management skills and the ability to interface cross-functionally with other expertise areas including clinical and operational personnel is required
- Understanding of drug development and submission requirements is required
- Manufacturing and logistics understanding/experience is preferred
- Ability to work independently and in a matrixed team environment is required
- Has demonstrated to be able to make decisions independently, innovate and is strategic thinker with broad vision
- Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required
- Experienced quality assurance/compliance mindset is required
- In addition to fluent English, able to read, write and speak at least one other European language
- Has a data driven mindset and acts accordingly
- Fully independent, self-directed and physically and mentally able to work remotely
- Travel may be required up to 10% of time
- Eligible to work in the European Union