Associate scientist Quality Control

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Leiden is seeking an (Associate) Scientist in Microbiology, Quality Control. The role focuses on supporting microbiological testing for Drug Substance and Drug Product within the Leiden QC department of the Johnson & Johnson Supply Chain.

You will troubleshoot testing methods, drive improvements, and prepare protocols and reports for continuous improvement projects, reporting to the QC Microbiology team lead.

Qualifications

• PhD or equivalent in Biochemistry, Microbiology or related field is required.
• Minimum 6 years in the pharmaceutical industry in QC with a microbiology focus.
• Regulatory GMP knowledge; familiarity with FDA and EU GMP.
• Strong ability to work independently and in team environments; stakeholder management.

Responsibilities

• Support microbiological testing for Drug Substance and Drug Product in QC.
• Troubleshoot microbiological methods and drive improvements to test methods.
• Prepare protocols and reports for ongoing continuous improvement projects.
• Plan resources and equipment for current activities; report to QC Manager.

Skills

Lab experience

Analytical testing

Statistical analysis

Cross-functional collaboration

Project management

Lean/Greenbelt

Education

PhD in Biochemistry/Microbiology

Tools

R Studio

Minitab

Matlab

Electronic document management

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
• 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

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 (QC), 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

• 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, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.