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Stability Scientist

Leiden
You want to be a key player in the design, execution and evaluation of stability profiles and qualification of reference materials for novel vaccines during the clinical development and preparation for future commercialization.

Bedrijfsnaam

A scientific insourcing organization for the pharmaceutiical industry

Locatie

Leiden

Functie omschrijving

  • Manage the various stability studies of novel vaccines
  • Focus on review and approval of various scientific protocols, reports and documentation for IND/CTA filing
  • Provide scientific input in different CMC project teams
  • Ensure compliance with local and country regulations and guidelines

Uitdaging

  • There are many opportunities within the organization for further personal development
  • A responsible and challenging position with a lot of diversity
  • Input of your own ideas are always appreciated

Profiel kandidaat

Qualifications

  • You have a MSc or PhD Degree in Biochemistry, Pharmacy, or equivalent life sciences degree
  • A minimum of 2-3 years relevant pharmaceutical industry experience and working under GMP standards
  • Experience with stability study management
  • Experience with analytical method qualification and validation
  • Experience in writing of various scientific protocols, reports and documentation for IND/CTA/BLA/MAA filing is a big advantage


Personal characteristics
Since different CMC projects are carried out in teams comprising members from different departments, teamwork and flexibility are two very important characteristics that are required attributes.
You have excellent communication and soft skills. You will need to effectively communicate with other scientists, management, team members and client contacts.

Bedrijfsprofiel

Our principal works with his own teams of motivated people with a can-do mentality at the location of their clients. These are mostly pharmaceutical companies with an international group of employees. Working together is extremely important for our principal and having fun in what you do is of course part of that! There are monthly team lunches, team outings and awards are given to colleagues.

Arbeidsvoorwaarden

  • A salary that matches your experience and education
  • 31 holidays

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