Senior CMC Manager to iCoat Medical

iCoat Medical is a clinical stage, immunotherapy company built around and upon a very strong pre-clinical background that is the result of decades of research and product development that has been conducted in very close collaboration with leading academic institutions in Sweden and Japan.

The company is now on an exciting journey towards commercialization of its products with the aim to improve the outcome of organ transplantations and help patients across the world who is in need of a new organ. The innovation is based on a coating treatment of donor organs prior to transplantation which makes them less recognizable for the immune system of the patient.

iCoat Medical consists of a highly qualified R&D team who's specialized in different parts of pre-clinical and clinical studies and management of people with a proven commercial background. The team now needs to be reinforced with knowledge in chemistry, manufacturing, and controls (CMC) and is on the lookout for a CMC-manager with extended experience from industry-leading companies and with strong industry network to join this journey.

In this role you will

• Manage product design, production and projects related to product development
• Coordinate the overall pharmaceutical development in collaboration with CMOs
• Oversight and guide regulatory interactions relating to the IMPD
• Manage the drug product supply chain during clinical studies
• Participate in future commercialization of the company’s product portfolio

Qualifications and key experience

• Minimum MSc degree in chemistry or related field
• +10 years of experience within CMC from industry-leading companies and strong industry network.

Previous experience in:

• Leading relations with contract manufacturing organizations (CMOs)
• Writing investigational medicinal product dossier (IMPD)
• Leading regulatory affairs regarding manufacturing of investigational medicinal products (IMP) on an international level
• Handling IMP supply chains end to end during clinical trials

Desirable experience

• PhD degree in chemistry
• Drug substance synthesis and aseptic/injectable Drug Products.
• Drug Products in transplantation
• Drug Substances with polymeric characteristics
• European and American regulatory landscape
• Experience of clinical trials in the European and American regions
• Orphan Drug-centered pharmaceutical companies

Other important aspects

• Fluent in English, preferably also in Swedish
• Entrepreneurial mindset and eager to join a small but ambitious company
• Can be based in either Stockholm or Uppsala, Sweden
• Limited amount of travel is to be expected

This position is a key role in iCoat Medical’s journey going from research stage to helping patients around the world who need a transplanted organ. You get the opportunity to work in a competent and dynamic team in a global setting.

Interested?

For this recruitment process, iCoat Medical is collaborating with Mpya Sci & Tech.
Please submit your application no later than the 17th of February. Contact Talent Advisor Ellinor Crafoord or Emelie Gralberg for further questions. Ellinor: +46721765167, ellinor.crafoord@mpyascitech.com Emelie: +46728886705, emelie.gralberg@mpyascitech.com.

About iCoat Medical

iCoat Medical is a clinical stage, immunotherapy company focusing on reducing and preventing ischemia reperfusion injuries by developing novel pharmaceutical products. The company is one of the world’s leading R&D-centered organizations within innate immunology and is systematically expanding its pipeline using its proprietary coating-technology platform. iCoat Medical’s lead candidate TUM012 is developed to improve the outcome of organ transplantations. The company’s unique ex-vivo coating of the grafts has the ambition of being an integral part in the transplant procedures of tomorrow. iCoat Medical has operations in Uppsala, Lund and Malmö, and is headquartered in Stockholm.