NPI lead QC

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Johnson & Johnson Innovative Medicine we are searching for a NPI lead QC.

Keywords

• New Product Introduction (NPI)
• Analytical method transfer
• QC
• GMP
• Large molecules

We are looking for an enthusiastic Associate Scientist Quality Control to work as NPI lead in the QC Leiden NPI team. In this team, you will be department project lead and responsible for introduction of new products into the Leiden lab, both for products manufactured in Leiden and elsewhere. The NPI team ensures flawless NPI introduction meeting customer demands while ensuring robustness and feasibility are maintained. As NPI project lead, you will ensure alignment between customers, local and global stakeholders.

Responsibilities:

• SPOC for all NPI activities, from Phase 1 to Late Stage NPIs throughout the CMC stage gates;
• Project lead for NPI transfers, laboratory NPI capacity increase initiatives, and new technology’s introduction (e.g. project management, leading the Leiden team, budget control, etc.);
• Ensure NPI testing plan is aligned with the platform testing strategy;
• Support the testing teams aligning NPI volumes with testing capacity;
• Co-ordinating the analytical method transfer end-to-end;
• Partner with local and global stakeholders (e.g. DPDS, PQM, Technical Operations, Operations, JSC QC sites, etc.);
• Alignment of NPI global teams and department testing teams needs and requirements to ensure flawless and on-time NPI introduction;
• Laboratory testing readiness;
• Ensure new products introduced have required robustness and reliability of a commercial lab;
• Establish and improve standards for content and quality of NPI processes (change controls, method transfers, documentation, communication, etc.).

Profile

The ideal candidate has the follow education, experience and skills:

• Master/bachelor’s degree in Life Sciences, analytical chemistry, biochemistry, or comparable;
• At least 4 years of experience in a laboratory/pharmaceutical environment;
• Project management experience;
• Experience with new product introduction;
• Experience in analytical method transfers;
• Knowledgeable about a wide range of large molecule analytical methods;
• Excellent communication skills (oral and written English);
• Self-starter, initiative-rich, team player;
• Interpersonal skills and engaged in contact with personnel at all levels within the organisation;
• Shown to have excellent safety and GMP awareness and experience;
• A quality, compliance and business minded attitude;
• Flexible and agile, capable of handling multiple projects and changing priorities.

Benefits

Project for at least 11 months, 50% onsite.

Company profile

UBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd">

J&J Innovative Medicine (Janssen Biologics) creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

<

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2400068)