Associate scientist Quality Control

Johnson & Johnson Innovative Medicine; Sassenheim; In loco; EUR 54.000 - 85.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Descrizione del lavoro

Johnson & Johnson in Leiden seeks a (Associate) Scientist to join the Microbiology testing team within QC. You will support microbiological testing for Drug Substance and Drug Product, and drive improvements in test methods.

The role requires a PhD or equivalent in Biochemistry or Microbiology with 6+ years in pharma QC, strong GMP knowledge, and independent collaboration with cross-functional teams.

Competenze

• PhD or equivalent in Biochemistry, Microbiology or related field required.
• Minimum 6 years in pharma QC with microbiology focus.
• Regulatory GMP knowledge for FDA and EU.
• Able to work independently and in teams, manage stakeholders.
• Analytical skills for statistical analyses and deviation management.

Mansioni

• Support microbiological testing for Drug Substance and Drug Product.
• Lead continuous improvement projects, troubleshoot methods, prepare protocols.
• Plan resources and equipment; report to QC Microbiology manager.
• Coordinate with multiple CMOs for release testing.

Conoscenze

Laboratory experience

Technical proficiency

Project management

AI concepts awareness

Regulatory knowledge

Formazione

PhD or equivalent in Biochemistry/Microbiology

Strumenti

LEAN

Greenbelt

Descrizione del lavoro

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

Job Sub Function

Job Category

All Job Posting Locations:

Leiden, South Holland, Netherlands, Sassenheim, Netherlands

Job Description

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

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, 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.