QC-Raw Materials Project Lead

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:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Leiden, Netherlands

Job Description:

Janssen Biologics is currently recruiting a QC-Raw Material (RM) Project Lead within our Quality Control department. The successful candidate needs to understand the QC testing environment and has relevant educational background. The candidate is responsible for on time execution of QC RM projects, including but not limited to: Introduction of new RMs, Vendor and compendial changes. 

Janssen Biologics B.V. is part of Johnson & Johnson Innovative Medicine. Janssen Biologics B.V. is a multinational pharmaceutical company that has been leader in the field of biomedicines for more than 25 years. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics is part of the Johnson & Johnson family of companies. 

The Leiden Quality Control department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and advanced therapies manufacturing site that is part of the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site.

The Leiden QC-RM Team has a unique global responsibility and exposure by being the RM Global SMEs for large molecule Biotherapeutics (Large Molecule, Vaccine, and Advanced Therapy) products within QC laboratories and by partnering with multiple sites and teams both internally and externally to perform RM testing

You Will Be Responsible For:

• Coordinate QC-RM project activities in relation to analytical method transfers, new laboratory introduction and technology transfers and ensure on time completion per agreed timelines.
• Creates, reviews, and approves related documentation.
• Leads and participates in meetings with various local/global/internal/external stakeholders in the frame of project.
• Leads QC-RM related deviations and non-conformances and coordinates appropriate corrective/preventive actions.
• Leads and drives continuous improvement projects.
• Raising and managing team purchase order (POs) for RM testing.

Qualifications/Requirements:

• Bachelor’s degree (or equivalent) in a relevant discipline with 4 to 6 years of related working experience. 
• Proven experience in quality control and raw materials testing.
• Excellent verbal and written communication skills (English), including ability to effectively communicate with Global internal and external stakeholders. 
• Affinity and experience with systems like Elims, SAP, Excel and financial systems ( i.e.Ariba)  to accurately record and analyze data and finances.
• Ability to work and communicate effectively in a team environment.
• Proactive, pragmatic with excellent analytical and problem-solving skills.

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 anticipated base pay range for this position is 52.200 to 84.180 on an annual basis and includes 8% holiday allowance.