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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Scientist, Quality Control

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to create 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/.

Johnson & Johnson Services Inc., a member of the Johnson & Johnson Family of Companies, is recruiting a QC Scientist. This position will be located in Leiden, Netherlands.

The Leiden Quality Control (QC) Leiden department is a Business Unit within the Leiden site, a biotherapeutics and vaccines manufacturing site belonging to the Johnson & Johnson Supply Chain. The Leiden QC department is responsible for raw material, in-process, and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within the Johnson & Johnson Supply Chain, and by partnering with multiple Contract Manufacturing Organizations to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise.

The Scientist will be part of the testing teams within the Quality Control (QC) department, acting as the scientific responsible person to support the analytical testing aspects associated with Drug Substance and Drug Product manufacturing. This role involves troubleshooting of analytical methods, ensuring smooth entry of new methods into QC, proactively making improvements to test methods to stimulate executional excellence, managing product related deviations, leading investigations and analytical method transfers, and providing subject matter expertise for new equipment. Additional responsibilities include participating as a Subject Matter Expert (SME) in internal and external audits, writing observation responses, and developing the next generation QC Scientists. The Scientist will report to a (Sr) Manager of the QC testing teams.

Major duties and responsibilities:

Method Management: Act as the gatekeeper for the introduction of new analytical methods in the laboratory, ensuring that the scientific aspects are thoroughly assessed. Conduct feasibility experiments independently as necessary and continuously seek opportunities for method improvements in performance and execution. Oversee the entire lifecycle management of analytical methods, including their validation and verification. Furthermore, facilitate interactions with the Analytical Development (AD) team, particularly when methods transition into Quality Control (QC).

- Documentation and Compliance: As a Subject Matter Expert (SME) or delegate of QC Management, authors, reviews, and approves critical documents, including standard operating procedures. Ensure that this documentation serves as a critical component in maintaining compliance with regulatory standards for Good Manufacturing Practices (GMP). Design and create protocols related to compliant test method transfer and validation.

- Non-Conformance Investigation: You will be responsible for reviewing investigations related to non-conformances to ensure the highest quality standards are maintained. Your role will involve analyzing and interpreting data to identify discrepancies.

- Technical leadership: Apply scientific expertise to investigate and resolve complex technical issues in the laboratory. Lead investigations as a Subject Matter Expert, defining and implementing corrective and preventive actions (CAPA) alongside effectiveness checks. Furthermore, managing and documenting changes to a system, process, or product (Change Controls). You will assess the impact of the change, minimize risks, and ensure that all changes are approved, implemented, and monitored to ensure quality, safety, and compliance.

- Stakeholder management: Develop comprehensive business cases to justify the needs for new analytical equipment. Collaborate pro-actively with Analytical Development, Global QC, Local QC, and IT teams to select, purchase, and qualify new analytical equipment for QC laboratories.

Identify and seek out external resources (e.g. Parenteral Drug Association, International Society for Pharmaceutical Engineering, ) to build or enhance understanding of scientific discipline.

- Mentorship: Mentor and coach associate scientists and technicians, fostering a culture of excellence and continuous improvement within the team.

-Relationship: Reports to manager QC

Who are you?

- Educational Background: PhD or equivalent in Chemistry, Pharmacy, Biochemistry, Microbiology or a related field is required.

- Experience: A minimum of 6 years in the pharmaceutical industry is required, specifically within QC, with a strong emphasis on microbiology, analytical sciences, or protein sciences. This includes expertise in degradation analysis, method development/improvement, method validation and analytical method transfers. Additionally, a strong understanding of monoclonal antibodies is essential for this role.

- Regulatory Knowledge: Comprehensive understanding of worldwide regulatory GMP requirements and knowledge of FDA and EU GMP.

- Interpersonal Skills: Strong ability to work independently and in team environments, effectively managing stakeholder relationships and addressing biological testing issues. Asserts personal ideas and opinions using persuasion to influence others.

- Analytical Expertise: You have the ability to critically assess analytical investigation reports and conduct statistical analyses (R studio, minitab Matlab). Familiarity with electronic documents and deviation management systems is desirable.

Skills/Competencies:

- Laboratory Experience: Extensive operational experience in a Pharmaceutical QC laboratory, specifically with Drug Substance and Drug Product processes. To be trained in and qualified for the assays that you are SME for and be able to perform investigational testing and train technicians for new methods.

- Technical Proficiency: Strong understanding of analytical technical transfer processes, compliance requirements, and troubleshooting skills. Advanced knowledge of modern methodologies; familiarity with cell cultures, advanced separation methods (cIEF, cSDS), microbiology methods, or compendial methods are a distinct advantage.

- Project Management: Demonstrated project management skills, able to effectively oversee and coordinate multiple projects, LEAN, Greenbelt certification.

If you are passionate about contributing to the advancement of pharmaceutical science, are driven by excellence, and possess the required skills and qualifications, we invite you to apply for this exciting opportunity!