Our client, a prominent biologics manufacturer, is looking for a motivated and detail-oriented professional to join their team as an NPI Lead. As a valued member of the New Product Introduction (NPI) team, you will oversee the successful integration of new products into our client's laboratory facilities.
As the NPI Lead, you will be responsible for managing the smooth introduction of new products into the laboratory while ensuring compliance with customer demands, as well as lab robustness and feasibility. You will serve as the main point of contact for NPI activities, including Phase 1 to Late Stage NPIs, during the CMC stage gates.
- Manage NPI transfers, laboratory NPI capacity increase initiatives, and new technologies introduction.
- Prepare business cases and budget estimates for NPIs requests.
- Ensure NPI testing plans align with the platform testing strategy and support testing teams in aligning NPI volumes with testing capacity.
- Oversee analytical method transfer and raw materials qualification processes.
- Work with local and global stakeholders to ensure flawless and timely NPI introductions.
- Coordinate NPI global teams and department testing team needs and requirements.
- Establish and enhance standards for NPI processes' content and quality.
- Bachelor's or Master's degree in Life Sciences, Analytical Chemistry, Biochemistry, or equivalent.
- At least 2-4 years of laboratory or pharmaceutical experience.
- Knowledgeable in project management, CMC, analytical method transfers, and/or raw materials qualifications.
- Familiarity with a broad range of large molecule analytical methods.
- Excellent English communication skills, both written and oral.
- A self-starter with a strong GMP and safety awareness.
- Strong interpersonal skills and the ability to engage with all levels of the organization.
- A quality, compliance, and business-oriented mindset.
- The ability to multitask and handle shifting priorities.
- Strategic thinking and the ability to balance short- and long-term objectives.
- 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; 22376