Associate scientist Quality Control

Johnson Johnson; Leiden; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Johnson & Johnson Leiden is seeking a (Associate) scientist for the Microbiology testing team in the Leiden QC department. The role focuses on supporting microbiological testing for Drug Substance and Drug Product with a strong emphasis on method development, transfer and compliance.

The successful candidate will collaborate across teams, contribute to continuous improvement projects, and report to the QC Microbiology manager. Leiden site emphasizes bio therapeutics and vaccines manufacturing.

Qualifications

• PhD or equivalent in Biochemistry, Microbiology or a related field is required.
• Minimum of 6 years in the pharmaceutical industry with a QC microbiology focus.
• Regulatory GMP knowledge including FDA/EU GMP is essential.
• Strong interpersonal and analytical skills, able to work independently or in teams.

Responsabilités

• Be part of the Microbiology testing team within the QC department.
• Support microbiological testing related to Drug Substance and Drug Product manufacturing.
• Contribute to continuous improvement projects and document protocols and reports.
• Plan resources and equipment for ongoing activities of the project.
• Report to the Senior Manager of the QC Microbiological testing team.

Connaissances

Microbiology testing

Analytical method transfer

Regulatory GMP knowledge

Project management

Formation

PhD in Biochemistry or Microbiology

Outils

R Studio

Minitab

MATLAB

Description du poste

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

• Leiden, South Holland, Netherlands
• Sassenheim, Netherlands

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.

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 Description:

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