NPI Quality Control Lead

Location Leiden
Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Oliver Holding Fay

Contact email: o.fay@panda-int.com
Job ref: 16027
Published: 16 days ago

We are looking for an enthusiastic NPI lead position to join QC team at a booming biotech company in the Netherlands. In this team, you will be department project lead and responsible for introduction of new products.

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 technology’s 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, JSC QC 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.)

PROFILE

  • 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)
  • Shown to have excellent safety and GMP awareness and experience

START DATE ASAP

HOURS 40 hours a week

DURATION 6 months with a high chance of extension

LOCATION Leiden, Netherlands, 2 days onsite / 3 days offsite

Interested?

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme?

For more information, please contact Oliver Holding Fay on +31 (0)20 20 44 502 or o.fay@panda-int.com