QC Scientist NPI Lead

Location Leiden
Discipline: Biotechnology
Contact name: Michelle Terraneo

Contact email: m.terraneo@panda-int.com
Job ref: 11661
Published: about 1 month ago

Do you want to work for THE most innovative Biotech Giant in Leiden? Then read on!

For the NPI team in Leiden, i'm looking for a QC NPI Lead! 

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 NPI lead 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
• 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
• Raw materials qualification
• 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.)

Qualifications and Competences:
• Master/Bachelor degree in Life Sciences, analytical chemistry, bio chemistry, or comparable
• At least 4 years’ experience in a laboratory/pharmaceutical environment
• Preferably project management experience
• Experience with new product introduction.
• Experience in analytical method transfers and/or raw materials qualifications
• 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


Send me your CV + Contact details to: m.terraneo@panda-int.com and i will call you ASAP!