Job opening - NPI Lead | Analyst Quality Control | Yacht Life Sciences in Leiden

summary

leiden, zuid-holland
€5,100 per month
permanent

job category
engineering

job details

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.

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.

experience
4
skills
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
qualifications
HBO,WO

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npi lead | analyst quality control | yacht life sciences.

job details

experience

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qualifications

the application process.

apply with randstad.

we'll give you a call.

getting you registered.

compliance check.

reference and background check.

the perfect job for you.

the interview.

start your new job.

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