Are you an experienced professional with a passion for quality control and new product introduction? My client, an innovative Biotech is seeking an QC Analyst – NPI Lead to join their dynamic NPI team at the Leiden manufacturing site.
About the Role
As a member of the NPI team, you will:
Act as the Single Point of Contact (SPOC) for all NPI activities, from Phase 1 to Late Stage NPIs through the CMC stage gates.
Lead projects for NPI transfers, laboratory capacity expansions, and the introduction of new technologies.
Collaborate with cross-functional local and global stakeholders to ensure seamless and timely NPI implementation.
Align NPI testing plans with platform testing strategies and coordinate analytical method transfers end-to-end.
Key Responsibilities New Product Introduction & Project Leadership:
Serve as project lead for NPI transfers, laboratory readiness initiatives, and technology introductions.
Manage budgets, lead local teams, and ensure alignment between global and department testing teams.
Guarantee robustness and reliability of new products in a commercial lab setting.
Collaboration & Coordination:
Partner with diverse stakeholders, including DPDS, PQM, Technical Operations, JSC QC sites, and others.
Ensure laboratory testing readiness by aligning NPI volumes with capacity.
Establish and improve standards for NPI processes, such as method transfers, documentation, and change controls.
Process Optimization & Compliance:
Develop and refine standards to enhance the quality and consistency of NPI processes.
Maintain a high level of GMP and safety compliance, fostering a quality and business-oriented mindset.
What We Are Looking For Education & Experience:
Master’s or bachelor’s degree in Life Sciences, Analytical Chemistry, Biochemistry, or a comparable field.
At least 4 years of experience in a laboratory or pharmaceutical environment.
Proven project management experience, with a preference for experience in NPI and analytical method transfers.
Technical Expertise:
Knowledge of a broad range of large molecule analytical methods.
Strong understanding of GMP requirements and safety practices.
Practicalties:
Location: Leiden, Netherlands (Hybrid position)
Contract: 11-month (with potential for extension)
Start Date: ASAP
Interested?
Send your CV to Khanyi Mabena at k.mabena@panda-int.com or contact her directly at +31 2020 44502 for more information.