Johnson & Johnson / Viral Launch Facility looking for a
Senior Manufacturing Specialist Drug product
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without diseases. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and hearts to pursue the most promising science into life changing products for patients around the globe. One of the key focus area’s for Janssen in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.
At the Janssen site in Leiden (located at the Bioscience Park), we work with more than 2100 talented and multi-skilled people in 5 different business units. We produce different products and pioneer solutions to deliver better health. This vacancy is for Business Unit 2: The Viral Launch Facility (VLF).
The VLF is Janssen’s state-of-the-art GMP manufacturing facility from which we launch and grow new and innovative Gene Therapeutic products. The facility has two manufacturing suites. In suite 1 we produce Drug Substance (e.g. cell & virus cultivation and purification processes). In suite 2 we produce Drug Product (e.g. Fill & Finish processes) for the final product.
Both production suites in the VLF are currently in the final stage of preparation for Phase 3 and commercial production to accommodate the transfer of new products to the VLF per 2024.
Are you excited to set up a plant with new equipment and scale up the processes within a global company? Do you get energy from working together and contribute to improve the life of patients?
Then this is your job!
You will become part of the Centre of Expertise (CoE) team. The CoE team consists of 12 highly skilled professionals (Manufacturing specialists on Drug Substance, Drug Product and Single Use). CoE ensures that our production equipment and single use flow paths in the VLF are operational, safe, GMP compliant, robust and ready for the future.
As system owners we enable operations can process first time right with our equipment with guidance varying from initial training, writing procedures and instructions. We enable Operations to excel in production reliability.
During the project phase you will work on the technology transfer from R&D to manufacturing. You will participate in manufacturing readiness initiatives of new equipment and processes. This includes process documentation, training of operations, and qualification of the systems and processes.
As soon as the facility is in operation you will further develop the manufacturing process to achieve a stable and reliable operation. In your role as system owner, you are the first responsible person to perform acute troubleshooting and support of cGMP batches in the VLF.
Besides this you will be playing a key role in the further development of the Business Unit in terms of new product introduction, efficiency, and reliability.
Responsibilities and the impact YOU will have:
As a Senior Manufacturing Specialist Drug Product you will be a system & equipment owner, troubleshooter, and project member or – lead:
As Senior Manufacturing Specialist you:
· Manages and uses the business processes, with which the equipment performance is analyzed and makes proposals for improvement points with the greatest impact on a specific objective (safety, quality, reliability/efficiency and costs).
· Identify, plan and control changes for system and process robustness (team task allocation and prioritization 0-3 months timeframe);
· Lead/owner business processes and projects that are mainly system or facility related, with peers in service oriented or operating departments.
As system / equipment owner you:
· make sure that the production equipment is in validated state, documentation is up to date, well maintained, and production capacity meets planning.
· will play a key role in the interaction between our Operation Department on one site and the Maintenance and Engineering teams on the other site.
· generate the process equipment related reports and KPI’s. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity).
· initiate and execute test protocols that help to improve the system or process.
As troubleshooter you:
· are the first responsible person to perform acute troubleshooting and support of cGMP batches regarding the Drug Product processes in the VLF (fill of the product in vials).
· detect (Gemba walk) and solve acute problems and communicate possible abnormalities.
As project member/lead you:
· be involved by acquiring and introducing new equipment for the manufacturing of new types of products.
· participate in root cause investigations of complex deviations and for the implementation of preventive actions.
· participate in handling of compliance records (change control, events, CAPA, deviations).
· lead process excellence activities to continuously improve the work as well as personal skills.
· Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
· 8-15 years’ experience in a biotechnology or biopharmaceutical industry environment. Minimal 6 years for WO graduate
· Proven knowledge in at least one of the following aspects: Annex 1, Drug Product Filling, Visual Inspection.
· Proactively sees and finds work, knowing and visibly taking ownership of responsibilities.
· Excellent communication skills, written and verbal in English.
· Preferred knowledge/ In depth, up-to-date knowledge of DP labelling,
· Experience in a GMP regulated environment and proven knowledge off Single Use systems.
Preferred key competencies:
· Decisive, pragmatic and persevering with a can-do mentality.
· Stimulates open communication and can adapt communication style to the situation.
· Recognizes, acknowledges, and involves employees with different backgrounds, talents, knowledge and ideas.
· Dares to say no, can deal with uncertainties, escalates clearly and timely.
· Can absorb complex information and is analytical: successfully recognizes and solves problems by actively gathering information, analyzing, and connecting multiple signals and sources and discovering the root cause/suggesting a solution to the problem.
· Ability to create a path forward even if the solution is not yet clear or there is no standard process.
This is what awaits YOU at J&J:
· An opportunity to be part of a global market leader, with a strong global network of talent and expertise, with opportunities to learn or move to different cultures and work environments.
· A dynamic and inspiring working environment with career opportunities and continuous personal and professional development in areas of technology and leadership.
· Personal Development Plan – such as access to further education & training, Insights Discovery training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
· Many employees benefits like:
- Flexible working arrangements with J&J Flex, enabling you to work from home;
- provides a middle wage pension plan . It is company sponsored with an employee contribution.
- 36 days holidays (based on full-time employment);
- a monthly allowance for a subscription to a sport center and a bike plan.
- Global Parenteral Leave policy offering 12 weeks of leave (birth/parenteral, adoption/foster care and parenteral) at 100% pay to parents.
Our Commitment to 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 in the Netherlands are 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. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
Are YOU interested?
If you are interested in this position and you are the enthusiastic Senior Manufacturing Specialist DP who enjoys implementing and making a new filling process operational, respond to this position.