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Drug Product GMP Specialist

Leiden, Netherlands

Description

At the Johnson & Johnson Company (JNJ) , 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 JNJ in Leiden is the development and production of Gene Therapeutic products to cure chronic diseases.

At the JNJ 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 Gene Therapeutic Facility (GTF).

The GTF is JNJ’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 GTF are in the final stage of preparation for Phase 3 and commercial production to accommodate the transfer of new products to the GTF by 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 Operations department/General Operations Team and strengthen our department with knowledge and expertise of the Drug Product process.

The General Operations Team consists of 10 professionals with in-depth knowledge of their specific role, being Manufacturing specialist, GMP specialist, Planner or Operations engineer. Together we are responsible for GMP, inspections, planning and project support within the operation department and the other departments.

In your role as GMP Specialist DP you will be responsible for the general GMP DP related procedures and support the production team and the rest of the GTF with specialized and in-depth knowledge and skills on the GMP DP processes and systems.  You will also work as a primary contact for the GTF regarding the Contamination Control Strategy and coordination and support of internal and external inspections.

During the preparation phase (the transfer of new products to the GTF in 2024) you will work on introducing a new DP process with all required GMP procedures.

Responsibilities and the impact YOU will have:

As GMP specialist DP, you will be responsible for:

·       Coordinating and writing the Contamination Control Strategy for GTF

·       Review general GTF GMP documentation and delegate improvements to keep the general GTF GMP documentation up to date.

·       Leading initiatives to ensure that the training system (Summit) is up to date and set up to support all GTF processes.

·       Training coordinator and responsible for the training-syllabi within the GTF.

·       Coordinator of documentation and training periodic review within the GTF.

·       Coordinator internal batch release.

·       Leading initiatives to keep the Quality Risk Analysis up to date.

·       Support in improvements on production processes and systems within the GTF.

·       Acting as a primary contact for the GTF and coordination and support of internal and external inspections.

·       Support Change Controls, project teams and GTF improvements.

Qualifications

Qualifications :

Qualifications:

·       Master’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).

·       2-8 years’ experience in a biotechnology or biopharmaceutical industry environment.

·       Good communication skills in Dutch and English, both verbally and in writing.

·       Knowledge of sterile processing, drug product filling and Annex 1 regulations.

·       Working knowledge with cGMP standards.

Preferred knowledge and experience:

·       Experience in Quality Systems

·       A preference for experience with Trackwise QEM, Truvault or similar automated systems.

·       Knowledge and experience with Lean methodology.

Preferred key competencies:

·       Resilience: continues to work calmly and effectively in the event of deadlines, challenges, changes and unexpected setbacks.  Does not compromise on the quality of own work, even when the pressure to do so is great.

·       Stress-resistant: Is realistic in what they can and cannot be achieved within a certain timeframe, dares to say 'no' when things are not feasible or do not appear to be feasible and suggests how and when it can be done. Sets deadlines, divide possible tasks and escalates clearly and timely if needed.

·       Quality oriented and precise: Likes to perform according to work instructions with the highest level of safety, compliance and quality.

·       Improvement mindset and a “Can do” attitude: Supports a progressive learning culture by encouraging and helping others to recognize and implement improvements and changes.

·       Collaboration: Is open to the opinions and ideas of others in the team. Actively listens to different points of view, perspectives, opinions, backgrounds, and preferences in order to propose solutions.

·       Clearly shows that the joint result is important and seeks collaboration based on the idea that collaboration leads to better performance for the company.

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 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”!

About Johnson & Johnson

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/.

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