Description
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 product 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 2400 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 Therapeutics 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!
Job Summary
Location : Leiden, Nederland
Business unit : Viral Launch Facility
Department : Operations
Function: Senior Manufacturing Supervisor Drug Product19)
Contract : Full Time (0.8-1.0 FTE)
Start date : Q4 2023
Paygrade : 26
Shift : Not now, maybe after 2026
You will become part of the Operations department . This department is responsible for on-time manufacturing and delivery of the planned batches against the high-quality standards and safety and compliance regulations that are applicable for Janssen’s product portfolio for Gene Therapeutic products.
The operation department is divided into different teams. There are manufacturing teams for Drug Substance production and manufacturing teams for Drug Product filling consisting of Manufacturing operators. The Manufacturing Operators are responsible for the actual on-time production, filling and delivery of the products.
Additional there is a General Operations Team consist of Manufacturing specialists, GMP specialists, a planner and Operations Engineers with in-depth operation knowledge and are responsible for GMP, inspections, planning and project support within the operation department and the other departments.
In your role as Senior Manufacturing Supervisor Drug Product , you are responsible for managing the output of the Drug Product filling line and visual inspection , against a safe and high-quality background. You are accountable for achieving production targets (on time production and delivery of the batches) while maintaining cost controls.
Besides this you will be playing a key role in Operations Management Team (Drug Substance & Drug Product Teams) of the Business Unit and provide leadership and direction for the Drug Product resources and activities. You are reporting directly to the Senior Manager Operations DP of the VLF.
During the preparation phase you will work (with(in) project teams) on the technology transfer of the Drug Product processes & equipment from R&D/vendors to the DP production facility. You will participate in manufacturing readiness initiatives of the new equipment and processes of the (new) Drug Product capability, including process documentation, qualification and define and set up training programs. During this phase, you will also recruit, train and develop your team of manufacturing operators (approximately 7-10 FTE in total).
Responsibilities and the impact YOU will have:
As a Senior Manufacturing Supervisor, you will be responsible for:
1. Supervising production (Fill/finish & inspections) operations to meet production goals and work on improvements.
During the project phase you ensure that the manufacturing operators are deployed to their strengths (in the different project teams) so that their operational knowledge is used to optimize future production processes.
2. Building, supporting and leading a group of (senior) manufacturing operators within the VLF operations department (people leader);
During the project phase you will build and recruit a new team of DP operators. Making the strategy and working schedule for personnel for the coming years that will full fill the business needs. Be responsible for the trainings plan and schedule for each operator to be ready for manufacturing.
3. First point of contact for the (sub) department within the VLF and the Leiden site.
During the project phase you will participate in various project teams with e.g the sending unit and engineering to ensure your department is operational ready.
Qualifications
Qualifications:
· Bachelor’s degree or higher in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
· 6-8 years’ experience in a biotechnology or biopharmaceutical industry environment with:
- experience in a cGMP environment and EHSS standards.
- Proven knowledge in sterile manufacturing processes and Drug product filling and knowledge about Annex1 regulations.
· 2-4 years’ experience as a people lead.
· Good communication in Dutch and English, both verbally and in writing.
· Knowledge and experience with Lean methodologies
Preferred key competencies:
· Resilience: can deal with changing priorities, challenges, and unexpected setbacks.
· You have a “Can do” attitude.
· Collaboration: Enthusiastic team player, outspoken and adaptable.
· Practical technical understanding and conceptual thinking.
· Be proactive and actively connects with peers/colleagues/stakeholders/external partners.
· Can communicate with impact.
This is what awaits YOU at J&J:
- Working in a passionate professional team on challenging projects and deliver medicines that changes patients lives and be a member of a Johnsons & Johnson company.
- 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 some days of the week;
- provides a middle wage pension plan . It is company sponsored with an employee contribution of 4%.
- 36 days holidays (based on full-time employment);
- a monthly allowance of 20 EUR 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 Senor Manufacturing Supervisor who is ready for a new challenge, respond to this position.