Product Development Manager Biopharmaceutical (f/m/d)

at an aspiring company with a breakthrough technology in tumor surgery
Standort Land Branche Referenz
Munich or Groningen International Life Sciences / Pharma MJ1469
Our client is an expanding company headquartered in Groningen, the Netherlands with offices in Munich, Germany who developed a patented, breakthrough technology for fluorescence image-guided surgery, enabling surgeons to detect tumor tissue more accurately and thus improve outcome. The technology platform consists of an injectable imaging agent and a highly sensitive detection device. Being an independent part of an international market leader in diagnostic imaging, the company offers the advantage of working in a dynamic company combined with the financial backing of an international well-established corporation.

The Product Development Manager (f/m/d) will be responsible for the development and manufacture of a novel antibody-dye conjugate. The contrast agent is a combination of a humanized monoclonal antibody and a fluorescent dye, which enables optical real-time detection of cancer tissue for image-guided surgery.

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Ihre Aufgaben

  • Supervise activities in development, manufacturing and control of the antibody-dye conjugate
  • Generate CMC documentation together with subject matter experts (SMEs) to support regulatory submissions (IMPD, IND, BLA)
  • Provide strategic direction, tactical oversight and technical expertise for all activities within the Product/Process Development area
  • Responsible of designing and scaling-up production processes from laboratory scale through industrial scale and transferring processes/methods to Contract Manufacture Organizations
  • Report to the Head of Development and work closely with Regulatory Affairs, Quality and other internal and external experts

Ihr Profil

  • PhD in Pharmaceutical Chemistry, Biochemical Engineering, Biochemistry, or a related discipline with expertise in production and registration of biopharmaceuticals
  • Several years in all aspects of process/product development
  • Profound experience with cGMP, GLP, process development/scale-up and methods/process validation, especially in the field of biopharmaceuticals
  • Record in early and specifically late stage development and manufacturing of large molecule (conjugate) drug products
  • Fluent in English, additional language is a plus

Ihre Chance

  • A key position in a dynamic environment
  • Fascinating challenge in high-end medicine
  • Be part of the introduction of a breakthrough technology for tumor surgery
  • Play a major role in the development of innovative products
  • Join a small and competent team in an exciting industry

Haben wir Ihr Interesse geweckt? Dann freuen wir uns, Sie kennen zu lernen!

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