Experience Inc. Jobs

Scientist, Quality Control - 2406202623W

Description

• This position will be based in Leiden.

• Full-time workweek present at our site.

• 1-year contract with intention to extend.

Change lives for the better.

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/.

THE OPPORTUNITY

How you can help.

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

The Scientist is part of the QC Analytical Separation team of the Quality Control (QC) department of Leiden QC, the Netherlands. The scientist acts as a project lead to support analytical testing aspects associated with Drug Substance and Drug Product manufacturing. This role is responsible for leading investigations & analytical transfer of methods. Furthermore, provides subject matter expertise on introduction of new equipment and troubleshooting of analytical methods. This position supports the introduction of new products to the QC laboratories and owns product related deviations. Additional activities include participating and acting as Subject Matter Expert (SME) during internal and external audits and writing observation responses. The scientist will report to the Manager QC Separations.

What you’ll do.

Key activities include, but are not limited to:

Technology:

• Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory.

• Owns deviations.

• Owns and leads change controls.

• Leads or supports investigations.

• Leads or supports risk assessments.

• Defines corrective and preventive actions (CAPA) and Effectiveness Checks.

• Authors, reviews, and approves documents as SME and may also do so as delegate of QC Management.

• Owns and authors system operating procedures and other GMP documents.

• Performs feasibility experimental work as needed.

Equipment:

• Develop Business Case to justify needs for new equipment.

• Works cross-functionally with the Analytical Development, Network QC, Local QC, IT, to select, purchase, and qualify new analytical equipment for the QC laboratories.

Promotes safe practices and behaviors:

• Reports immediately incidents to Environmental Health and Safety department, participates in investigations and identify measures to prevent similar accidents in the future.

• Demonstrate JNJ values.

Qualifications

IT’S ALL ABOUT YOU

To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:

• Master’s in chemistry, Pharmacy, Biochemistry or equivalent field is required, advanced scientific degree (PhD) is preferred.

• At least 6 years’ experience within the pharmaceutical industry, preferably in the field of analytical sciences (stability, method development, analytical method transfer).

• Ability to work independently and within team matrix environments.

• Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements.

• In depth knowledge of Quality Management Systems relating to laboratory operations.

• Ability to ensure objective critique of analytical investigation reports and statistical analysis.

• Ability to manage business plus quality relationship with stakeholders and support biological testing issues.

• Previous experience using electronic document and deviation management systems is desirable.

• Working knowledge of analytical technical transfers is desirable.

• In-depth knowledge and operational experience in a Pharmaceutical QC laboratory.

• Drug Substance and Drug Product experience.

• Strong knowledge of analytical technical transfer processes, compliance requirements and proven troubleshooting skills.

• Project Management skills are required.

• Strong technical knowledge of modern chromatographic methodologies. Knowledge of peptide and size exclusion chromatographic methods is a distinct advantage.

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

Closing date: Tuesday, 6 th of August, 2024.

Being part of Johnson & Johnson can change everything, including YOU

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Janssen Biologics (7266)

Job Function Quality Control

Req ID: 2406202623W