New Product Introduction Lead QC

Empresa: Kelly Services Netherlands
Tipo de trabalho: Contrato

For our client, an international Pharmaceutical, we are looking for a New Product Introduction Lead QC based inLeiden.

All applicants MUST have full legal authorization to work in the EU region independently and be fluent in both spoken and written English language.

Your role

In the New Product Introduction (NPI) team, you will be the 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:
  • 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 ( 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 ( DPDS, PQM, Technical Operations, Operations, One Lab 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.)

Your profile
  • Master/Bachelor degree in Life Sciences, analytical chemistry, bio chemistry, or comparable
  • At least 4 years' experience in a laboratory/pharmaceutical environment
  • 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)
  • Interpersonal skills and engaged in contact with personnel at all levels within the
  • 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

What do we offer
  • Contract via Kelly Services for 12 months; possible extension
  • Start date: ASAP
  • Salary indication depending on experience

Enquiries

Please do contact Marcella Henryati, Recruitment Consultant / M: When interested please apply with your English resume on our website:

About Kelly Services

It's more than a job. It's passion. Our vision is to provide the world's best workforce solutions. We are authentic, the industry founder. We believe in relationships, not transactions. We value teamwork, realizing that we are stronger together than as individuals. We take seriously the promises we make. We are passionate, dedicated and driven to excel. With us it has never been about being the biggest. It has always been about being the best and doing the right thing.

At our core, we are a community. Each day we welcome into our community the varied talents of all people who embrace our culture of service, teamwork and integrity. We offer the opportunity to work with the best companies in the world, and to make a difference in the communities in which we live and work.


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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement

In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.

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