GMP Specialist

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:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Sassenheim, Netherlands

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Lenti Viral Vector Facility

Janssen Biologics B.V., part of Johnson & Johnson, is setting up a new production facility in Sassenheim. This new facility will produce lentiviral vectors (LVV), which are used in the treatment of multiple myeloma, a disease affecting 160,000 patients globally. The project team is preparing for commercial production in 2025.

We are searching for the best talent for a GMP Specialist position in Sassenheim, Netherlands!

The GMP Specialist is responsible for GMP-related tasks in BU5 and supports the BU5 organization with specialized, in-depth knowledge and skills regarding GMP processes, systems, and compliance. This role requires the ability to devise effective solutions while collaborating and aligning with various stakeholders.

GMP Specialists are integral members of the broader Centre of Expertise (CoE) department. The CoE is crucial in supporting both the Operations (Ops) and New Product Introduction (NPI) departments, particularly regarding technical processes and GMP compliance (including Annex 1). The CoE plays a key role in translating developed processes into workable processes for the shop floor. The CoE always adheres to high-quality standards, safety, and compliance regulations applicable to LVV manufacturing.

You will be responsible for:

• Leading deviations and root cause investigations, ensuring timely follow-up and completion of non-conformance records.

• Writing and facilitating change controls to document introductions and changes in GMP production processes. Coordinating internal batch release.

• Reviewing general LVV GMP documentation and delegating improvements to keep GMP compliance up-to-date and participating in and facilitating quality risk assessments (QRA).

• Coordinating, supporting, and preparing activities during internal and external audits in the role of Primary Contact, Subject Matter Expert (SME), scribe, or back-office lead.

Qualifications / Requirements

• Bachelor’s or University degree in Science or Engineering preferred along side proven experience in a biotechnology or biopharmaceutical (GMP) production environment.

• Strong working knowledge of current Good Manufacturing Practice (cGMP) standards is essential; familiarity with Annex 1 regulations is preferred.’ Experience with quality systems (e.g., Comet, TruVault).

• Proficiency in Microsoft tools: Excel, Visio, Point, Word, and PowerPoint.

• Excellent communication skills in English; additional Dutch language skills are preferred.

• Strong influencing skills and excellent stakeholder management within a highly complex matrix organization.

At Janssen Biologic B.V., we are driven by our commitment to innovative medicine and the patients we serve. As a GMP Specialist, you will play a pivotal role in ensuring the highest standards of quality and compliance in our cutting-edge therapies. If you are passionate about science and eager to contribute to meaningful healthcare advancements, we invite you to apply.

Embrace the opportunity to be part of a team that transforms lives through groundbreaking medical solutions. Together, let’s champion the journey from lab to life and make a lasting impact on the world!

Apply today and help us shape the future of medicine.#RPOAMS