NPI Lead Analyst Quality Control Yacht Life Sciences

1 week geleden

Leiden, Nederland Yacht Voltijd

Bedrijfsomschrijving

About the Company

Johnson & Johnson Innovative Medicine is dedicated to developing, producing, and marketing vaccines and antibodies to prevent and treat infectious diseases. At the Leiden site, a team of talented and versatile professionals thrives in a dynamic culture centred on innovation and a proactive mindset.

As an Affirmative Action and Equal Opportunity Employer, Johnson & Johnson welcomes applications from all qualified individuals, regardless of race, colour, religion, gender, sexual orientation, gender identity, age, national origin, veteran status, or disability.

Johnson & Johnson Innovative Medicine plays a pivotal role in the commercial and clinical manufacturing of biotherapeutics and vaccines. By blending proven expertise with cutting-edge innovation, the company is committed to meeting today's healthcare challenges and preparing for the future. At Johnson & Johnson, passionate individuals collaborate in a forward-thinking environment, united by a shared vision of a world free from disease.

Why YACHT/Randstad Professionals ?

At Yacht, we don't just offer jobs - we provide a pathway to your professional growth. Join us for exciting roles at leading (biotech) companies, unparalleled networking opportunities, and tailored development plans.

Empower Your Ambitions

Your career aspirations are our priority. We work closely with you to find assignments that align with your goals and push you to the next level. From personalized coaching to exclusive training programs, knowledge-sharing sessions, and inspiring events, we ensure your skills and ambitions flourish.

A Gateway to Excellence

Be part of a thriving network of professionals and forward-thinking companies eager to collaborate, innovate, and share opportunities. With Yacht, you don't just grow - you thrive.

Join us and discover the difference. Your future starts here

Functieomschrijving

Job Description

We have a vacancy for a NPI Lead/Analyst Quality Control to work at Johnson & Johnson Innovative Medicine (Leiden).

In the QC Leiden NPI team, you will act as the department's project lead, responsible for introducing new products into the Leiden lab, whether these products are manufactured in Leiden or elsewhere. The NPI team ensures seamless product introductions that meet customer demands while maintaining the robustness and feasibility of a commercial lab. NPI project leads serve as key connectors, aligning efforts between customers and local and global stakeholders.

Essential Responsibilities and Accountabilities:

  • Single Point of Contact (SPOC) for all NPI activities, from Phase 1 through Late-Stage NPIs during the CMC stage gates.
  • Lead NPI transfer projects, laboratory capacity increase initiatives, and the introduction of new technologies (including project management, team leadership, budget control, etc.).
  • Ensure the NPI testing plan aligns with the platform's testing strategy.
  • Support testing teams by coordinating NPI volumes with available testing capacity.
  • Coordinate the end-to-end transfer of analytical methods.
Furthermore, you will:
  • Collaborate with local and global stakeholders (e.g., DPDS, PQM, Technical Operations, Operations, JSC QC sites, etc.).
  • Align global NPI teams and department testing teams' needs to ensure seamless and timely NPI introductions.
  • Oversee laboratory testing readiness for new products.
  • Ensure new products introduced meet the required robustness and reliability standards of a commercial lab.
  • Establish and enhance standards for the quality and content of NPI processes, including change controls, method transfers, documentation, and communication.
Functie-eisen

Job requirements

  • Master/bachelor's degree in Life Sciences, analytical chemistry, biochemistry, or comparable
  • At least 4 years' experience in a laboratory/pharmaceutical environment
  • Safety and GMP awareness and experience
  • Project management experience
  • Experienced with new product introduction.
  • Experienced in analytical method transfers
  • Knowledgeable about a wide range of large molecule analytical methods
  • A quality, compliance and business minded attitude
Arbeidsvoorwaarden

Terms of employment

We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.

This concerns a secondment contract for one year via Yacht with an initial assignment for 1 year at Johnson & Johnson Innovative Medicine with possibility of extension.

We will offer a competitive benefit package in line with the seniority of the position, with a salary between €4100 and €5000 gross per 4-week period (based on full-time employment)

Working full-time is preferred (32 or 36 hours can be discussed).

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