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(Sr) Project Manager Drug Substance Development (CMC, farma)

Are you an expert in the field of drug substance development (DSD) and do you have experience as a manager or supervisor, being able to lead a team to success? Then we have a great opportunity for you, where you will play a leading role in the development of novel drugs.

Job description

As a project manager DSD you will lead a project team and represent the CMC project team. You will be responsible for coordinating the deliverables for several CMC projects in alignment with DSD line management as well as other functional departments.

Responsibilities

  • Represent the drug substance development on the CMC team, acting as a single point of contact
  • As a people manager, ensuring that there is a stable team with a positive constructive atmosphere
  • Develop the most effective project strategy together with the DSD department and CMC team
  • Responsible for budget management within the DSD department
  • Able to generation proper risk assessment scenarios
  • Ensuring that technical content review of regulatory submission (module 3) has taken place and meets the set requirements.
  • Setting priorities and aligning them with the departments involved, constantly assessing and improving the efficiency of the processes and the team.

Profile

  • A minimum a Masters of PhD degree in chemistry, pharmacy or similar life science degree
  • At least 8 years of work experience within the pharmaceutical industry, preferably in drug development
  • Ability to lead and develop multidisciplinary teams of professionals
  • Extensive knowledge of GMP and regulatory process experience
  • Knowledge or affinity with the relevant test methods for vaccine development
  • A quality, compliance and business minded attitude and flexibility

Terms of employment

  • Employment: temporary contract with prospect of a permanent contract
  • Salary indication: from € 5000 to € 7000
  • Working hours: 40 hours per week
  • Location: Leiden region

Vacancy number: 16432