Project Lead Operations

Project Lead Operations CAR-T

Location: Ghent

Duration: 3 months (opportunity for a contract extension)

Working hours: 40 hours per week

Pay rate range: Competitive hourly rate

Language requirements: English and Flemish (English as minimum)

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centres in the Ghent area (Belgium). The Project Lead Operations is part of the Operations workstream and closely connected to the Quality and Tech Transfer workstreams. This position will be based at our two new manufacturing facilities (Obelisc & Tech Lane) in the leading Biotechnology Hub of Ghent, Belgium.

You will have the unique opportunity to gain deep knowledge & expertise in a highly innovative and future oriented environment with the ability to profoundly impact the trajectory of health of our patients.

roles and responsibilities

As Project Lead Operations you will be responsible to drive the projects from an operational perspective related start/scale-up of the facility (ramp-up program, MES program). In a challenging, fast-paced environment, you play a central role in the organization to drive change, in which you will have a direct impact on the CAR-T program.

By collaborating with various other functions (quality assurance, quality control, health and safety, information technology, operations, planning, etc.) you will support the start-up and scale-up of the CAR-T process.

You take ownership for your projects in the Manufacturing process and will handle all related requirements, including the following responsibilities:

• Act as project manager for operational projects related to the ramp-up program.

• Have a ‘boots on the ground mindset’ to make sure that the actions are driven to execution.

• Support the lean design and implementation of Information Technology systems (SAP, MES, S/4, ...)

• including future releases to continuously improve performance and compliance.

• Provide Operational expertise in the Technical Operations discussions based upon a combination of intensive GMP knowledge of ATMP’s, knowledge in aseptic techniques and extensive process knowledge of cell and gene therapy products.

• Immerse yourself in CAR-T processes, build up solid expertise, ensure timely development and implementation of a robust operational documentation framework, including operating procedures, work instructions, (electronic) batch records etc., and ensure adequate training of the organization.

• Ensure end-to-end overview of the flow of all material required in your area, including process material, documents, waste, samples.

• Identify risks and opportunities in relation to process, contamination, cross-contamination and mix-up control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QA, QC and operations management.

• Instil a mindset of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times.

how to succeed

Experience

Minimum 8 years of relevant work experience, preferably in aseptic manufacturing.

Qualification & skills:

• You have a Master’s Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …).

• You are an experienced project manager.

• You have a strong knowledge in aseptic manufacturing.

• You embrace diversity, equity, and inclusion.

• You have detailed knowledge of the shop floor manufacturing process.

• You have a start-up/can-do mindset, and you proactively search for solutions. - You prioritize, and provide clear instructions to peers.

• You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/guidelines which require strict execution.

• Your verbal and written communication skills enable you to influence without authority.

• You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.

• You are able to concisely summarize and present results.

• Experience with team-based collaborations is a must.

• Experience with equipment/systems commissioning/qualification/validation, IT systems, cell therapy (CAR-T) is an asset.

benefits

This role offers a very competitive hourly rate. This contract will run for 3 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. Options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.