Our client, a leading biologics manufacturer, is seeking an enthusiastic NPI Lead to join their dynamic team. As a key member of the New Product Introduction (NPI) team, you will be responsible for the coordination and introduction of new products into our client's laboratory facilities.
As the NPI Lead, you will play a critical role in managing the successful introduction of new products into the laboratory, ensuring that they meet customer demands while maintaining the robustness and feasibility of the lab. In this position, you will serve as the single point of contact for all NPI activities, from Phase 1 to Late Stage NPIs, throughout the CMC stage gates.
- Lead NPI transfers, laboratory NPI capacity increase initiatives, and new technologies introduction, from project management to budget control.
- Conduct business case and budget estimations for NPIs requests.
- Ensure NPI testing plan is aligned with the platform testing strategy and support testing teams in aligning NPI volumes with testing capacity.
- Coordinate the analytical method transfer end-to-end and oversee raw materials qualification.
- Partner with local and global stakeholders to ensure flawless and on-time NPI introduction.
- Align NPI global teams and department testing teams needs and requirements.
- Establish and improve standards for content and quality of NPI processes.
- Master's and/or Bachelor's degree in Life Sciences, Analytical Chemistry, Biochemistry, or comparable.
- At least 2-4 years of experience in a laboratory or pharmaceutical environment.
- Experience in project management, CMC, analytical method transfers, and/or raw materials qualifications.
- Knowledgeable about a wide range of large molecule analytical methods.
- Excellent communication skills, both oral and written, in English.
- A self-starter with excellent safety and GMP awareness and experience.
- Interpersonal skills and engagement with personnel at all levels within the organization.
- A quality, compliance, and business-minded attitude.
- Flexible and agile, capable of handling multiple projects and changing priorities.
- Strategic thinking and able to balance short and long-term priorities.
- Contract; 1 year via Oxford, realistic long-term perspective.
- Salary €2800 - €4600 based on experience.
- Holidays; 25.
- Full-time position.
- Region; Leiden.
- Opportunities for career growth and advancement.
- Vacancy number: 22129