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2 months ago

Principal Scientist (Bioanalytics)

5 063 - 7 088€
Work format
onsite
Work type
fulltime
Grade
senior
English
b2
Country
Netherlands
This vacancy is from Hirify.Global listVacancy from Hirify Global, list of international tech companies
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Job description

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TL;DR
Principal Scientist (Bioanalytics): Developing and optimizing bioanalytical methods for mRNA-LNP products with an accent on potency assays, Flow Cytometry, and ELISA. Focus on transferring pre-validated methods to GMP-compliant Quality Control departments and serving as a Subject Matter Expert for internal and external stakeholders.

Location: Geleen, Netherlands

Salary: €60,750–€85,050

Company

A global leader in life sciences dedicated to manufacturing the medicines of tomorrow across 30+ sites worldwide.

What you will do

  • Transfer, optimize, and develop bioanalytical methods to support product development and quality control.
  • Plan, execute, and document method pre-validation studies in accordance with regulatory requirements.
  • Author Standard Operating Procedures (SOPs) and provide technical support for cross-departmental validation documents.
  • Train colleagues and transfer pre-validated methods to the GMP-compliant Quality Control (QC) department.
  • Perform routine testing for development campaigns and stability studies.
  • Act as a Subject Matter Expert (SME) during interactions with internal stakeholders and external clients.

Requirements

  • PhD and multiple years of experience in analytical development.
  • Expertise in analytical development of Bioassays specifically for mRNA-LNP.
  • Practical experience in potency assays according to ICH and USP guidelines, with a focus on Flow Cytometry (FACS) and ELISA.
  • Deep understanding of statistical methods relevant to analytical method development and validation.
  • Practical experience with aseptic cellular handling.
  • Ability to lead and develop junior staff.

Nice to have

  • Experience with GMP-compliant documentation and laboratory practices.
  • Theoretical and hands-on experience with Sanger Sequencing, Oxford Nanopore, qPCR, or LC-MS.
  • Initial experience in project or customer management within an analytical development environment.

Culture & Benefits

  • Agile career opportunities within a dynamic and inclusive working culture.
  • Compensation programs designed to recognize high performance.
  • Access to a variety of global benefits dependent on role and location.
  • Ethical workplace emphasizing collaboration, accountability, and integrity.

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