Home >

Vacature Scientist QC NPI

Locatie

Leiden

Publicatiedatum

01-10-2020

Publicatie eindigt

01-01-2021

Opdrachtgever

ECHT! Connecting Professionals

Bedrijfsprofiel

Our client Altran is a world leader in R&D and engineering consulting. They work with clients in more than 20 countries to create and develop new products and services. Innovation is our guiding principle, with which we lead in a world where change is a constant factor.
In the Netherlands they also bring the most complex and innovative projects of the customers to life. More than 800 consultants use their expertise every day to improve the performance of their clients.
They can proudly say that they are the partner in the field of technical innovation and process improvement.

Functie omschrijving

We are looking for an enthusiastic Associate Scientist QC NPI (New Product Introduction) specialist to join the team.
In this team, you will be department project lead and responsible for introduction of new products into the 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 and Accountabilities:
• SPOC for all NPI activities, from Phase 1 to Late Stage NPI's throughout the CMC stage gates
• Business case and budget estimations for NPI's requests
• Project lead for NPI transfers, laboratory NPI capacity increase initiatives, and new technologies introduction (e.g. 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 (e.g. 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.)

Functie eisen

Qualifications and Competences:
• Master/Bachelor degree in Life Sciences, analytical chemistry, bio chemistry, or comparable
• At least 4 years’ experience in a laboratory/pharmaceutical environment
• Preferably 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)
• Self-starter, initiative-rich, team player
• Interpersonal skills and engaged in contact with personnel at all levels within the organization.
• 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

Arbeidsvoorwaarden

What do we offer:
• Salary between € 3000 and € 4500 gross per month. Depending on knowledge and experience.
• A variable bonus plan
• A lease car or mobility budget
• Flexible secondary conditions
• Extensive training programs through our Academy
• An annual budget for personal innovations
• An InnovationLAB, fully facilitated by our client, where you can work on your own creations, alone or together with colleagues with the same interests
Leiden Heeft Werk gebruikt cookies om bepaalde voorkeuren te onthouden en vacatures af te stemmen op je interesses.