Technical Project Leader

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Technical Project Leader

Job description/tasks

Together with the other TPL’s you’re responsible for the development, GMP production, and release of Soft Mist Inhalation formulations and final drug products. You’re responsible for the selection and characterization of drug substances, formulation design, and development of stable, bioequivalent, and manufacturable generic Soft Mist Inhalation formulations. Working closely with Softhale’s R&D Scientist and Device Engineers, your tasks can be described as follows:

  • Technical leadership of inhaled drug development programs at approved CRO/CDMO partners.
  • Plan and conduct scientific experiments to create prototype products.
  • Develop experimental programs and work plans and schedules to meet performance objectives.
  • Identify complex problems and offer effective solutions through the development or modification of test methodology.
  • Review test results in alignment with the project goals, identify causes of variances, and recommend solutions to achieve goals.
  • Schedule experiments and prioritize assignments to meet project objectives and deadlines.
  • Record accurate and complete experimental methods and results.
  • Adhere to federal, state, and local health, safety, and environmental regulations.
  • Execute duties in accordance with Softhale SOPs
  • Act as primary scientific contact to external collaborators.
  • Review and approve documents according to the project’s requirements.
  • Prepare regulatory documentation to support interactions with regulatory authorities

Success factors

  • You have a bachelor/master in pharmaceutical, biomedical or chemical science or related
  • You have at least 5 years of experience
  • You have experience or a great interest in respiratory diseases
  • You are fluent in English, both written and spoken
  • You are keen on working in an international environment
  • You are a pro-active, hands-on, love to solve problems, like to be challenged, autonomous, out of the box thinker

What is Softhale offering

You will start in a fast-growing innovative company. At this moment in time, they are at a critical point of development. You will join their mission to further advance and broaden the development of their platform and to build and launch a new generation of highly effective inhalable medicines on a global scale. Besides a great opportunity, you will receive a competitive salary.

Interested to learn more about this vacancy? Please contact:

Astrid van der Ploeg
+32 470 345054 or +32 11 28 6992