Quality Control Analyst – NPI Lead

Job title:

Quality Control Analyst – NPI Lead

Company:

Panda International

Job description

Introducing Panda Intelligence: Your Recruitment Partner in the Intricate World of Data and AI in Life Sciences↓Quality Control Analyst – NPI LeadQuality Control Analyst – NPI Lead Location Leiden, Netherlands
Business Sector Biotechnology
Contact email
Job ref 24105
Published about 3 hours agoQuality Control Analyst – NPI LeadAre 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 [email protected] or contact her directly at +31 2020 44502 for more information.

Expected salary

Location

Leiden, Zuid-Holland

Job date

Wed, 11 Dec 2024 07:51:55 GMT

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