Project Manager Technology Transfer at HAL Allergy

The TT Project Lead is responsible for the introduction of new processes or materials into the operational departments, such as Production and Quality Control. He/she leads teams of operational experts from Production, QA/QC and Regulatory Affairs, and represents Operations in R&D project teams. In addition, the TT Project Lead may provide technical and organisational support to post-marketing changes as part of the HAL product portfolio.

 

Responsibilities

  • You participate in multidisciplinary project teams and contribute to the project goal by delivering and executing operational activities and milestones.
  • You ensure high-quality of the work performed by the team and make sure that new and improved manufacturing processes/analytical methods comply with relevant regulatory guidelines (e.g., GMP).
  • You plan and prioritise own work, and co-ordinate that of project team members, in line with targets and to ensure that deadlines are met.
  • Work with and manage contacts with external organizations, analytical laboratories and technical consultants.
  • You play an advisory role/provide technical support within the Technology Transfer department.
  • Translate requests of client into a clear project scope/plan.

 

Qualifications

  • Minimum BSc degree in Life Sciences with a minimum of five years of relevant experience in pharmaceutical (CMC) product development or industry.
  • Solid experience in project management in the field of (bio-)pharmaceutical product development in an industrial setting.
  • Good knowledge of pharmaceutical processes like filtration, formulation, filling and freeze-drying.
  • Experience with technology transfer from Development and/or clients to GMP production.
  • Experience with regulatory submissions and/or variations, such as IMPD or Type II.
  • Good knowledge of GMP and relevant pharmaceutical regulatory guidelines.
  • Good knowledge of and experience with validation and transfer of manufacturing and analytical processes.

 

Personal skills

You are a result oriented professional with the ability to work on different types of (CMC) projects. You can communicate and cooperate well with different stakeholders of various levels in and outside the organisation. With different projects and deadlines ongoing, you are able to plan your work and that of the project teams well.

Find out more about drug development at Leiden Bio Science Park.

R&D