As a part of JSC QC Leiden situated at the Janssen Biologics Manufacturing site, the New Product Introduction (NPI) team is responsible for the coordination and introduction of new products into QC Leiden, from Phase 1 to Late Stage NPIs, supporting all testing laboratories in QC Leiden.
We are looking for an enthusiastic (Associate) Scientist QC NPI position to join 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 ensures robustness and feasibility of a commercial lab are maintained. The NPI project leads are the multi connector role that ensures alignment between customers, local and global stakeholders.
Responsibilities and Accountabilities:
- SPOC for all NPI activities, from Phase 1 to Late Stage NPIs throughout the CMC stage gates
- Independently deliver business case and budget estimations for NPIs requests
- Project lead for NPI transfers, laboratory NPI capacity increase initiatives, and new technologies 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
- Coordinating 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
- Independently handle and lead complex (quality) issues related to NPI projects or processes.
- Establish and improve standards for content and quality of NPI processes (change controls, method transfers, documentation, communication, etc.)
- Master/Bachelor degree in Life Sciences, analytical chemistry, bio chemistry, or comparable
- At least 6-8 years experience in a laboratory/pharmaceutical environment
- Project management experience, including identification, anticipation and mitigation of project risks
- 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 organization.
- 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
- Strategic thinking, balance short and long term priorities