CMO Project Manager at HAL Allergy

The CMO Project Manager is responsible for planning and managing the introduction of new products and/or technologies at HAL Allergy. As the key contact person for the customer, you act as liaison between the customer and the operational organization, such as Production, QA/QC and Supply Chain.

Tasks and responsibilities

  • Lead projects (of internal processes and CMO projects) in order to make changes in production processes possible. Strongly interact with different stakeholders involved in the project: external customer, QA, QC, manufacturing, etc.
  • Responsible for technical transfer of existing and new process technologies in production processes.
  • Provides insight and guidance to current processes and new production technologies. Improve and extend existing techniques in our production processes, including consequences for the production chain.
  • Ensure the transferred production processes meet GMP regulations.
  • If needed, prepare validation protocols for manufacturing processes. Surveillance and execution of validation tests.
  • Lead with aspects related with the projects as risk analysis, CAPA, change control, process investigations, continuous improvement etc.

Requirements

  • Minimum Bachelor’s Degree.
  • A minimum of 5 years of experience in the pharmaceutical industry in a relevant position.
  • Experience in managing projects, preferably projects with international customers.
  • Good understanding of GMP regulations.
  • Good knowledge of pharmaceutical processes like filtration, formulation and freeze-drying.

Personal & Professional Skills

  • Result oriented. Able to offer pragmatic solutions.
  • Pro-active.
  • Ability to think and act strategically.
  • Ability to stimulate teams and individuals.
  • Open mindset, flexible, able to adapt to different situations.
  • Good communication skills.
  • Proficient in both Dutch and English, both verbal and written.

Biotech Training Facility: unique professional GMP and biosafety courses in a state-of-the-art environment.

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