Associate Scientist Quality Control

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Leiden, South Holland, Netherlands, Sassenheim, Netherlands Job Description: (Associate) Scientist Microbiology, 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 (Associate) 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. Major duties and responsibilities: The (associate) scientist will be part of the Microbiology testing team within the QC department. The (associate) scientist will be acting as the scientific responsible person to support the microbiological testing aspects associated with Drug Substance and Drug Product manufacturing. This role is dedicated to a continuous improvement project and involves trouble shooting of microbiological methods, proactively making improvements to test methods to stimulate executional excellence, preparing protocols and reports for ongoing continuous improvement projects. Prepare the planning of resources and equipment for all ongoing activities related to the project. The (associate) scientist will report to the (Sr) Manager of the QC Microbiological testing team. Who are you? - Educational Background: PhD or equivalent in 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. This includes expertise in method development/improvement, method validation and analytical method transfers. - 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, 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! - Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity Required Skills: Microbiology, Quality Control (QC), Stakeholder Management, Troubleshooting Preferred Skills: Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy The anticipated base pay range for this position is: €53 500,00 - €85 445,00 Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bere