Head of CMC - Affibody

Do you want to be part of the development of new protein therapeutics at an innovative, exciting and expanding biotech company and help drive science to patients? 

Affibody is developing a portfolio of innovative drug projects, including proprietary programs targeting psoriasis, autoimmune diseases and oncology. 

Affibody co-operates with Alexion concerning autoimmune diseases and has several ongoing commercial relationships with several companies such as AbClon, Biotest, Daewoong, Daiichi Sankyo, GE Healthcare, Nordic Nanovector, and Swedish Orphan Biovitrum. 

The role in general
The Head of CMC will lead the CMC group at Affibody. The group is responsibility for identifying, selecting, overseeing, and managing Contract Manufacturing Organizations (CMOs) for scale-up, process optimization, manufacture and supply of Drug Substance (DS) and Drug Product (DP) to support non-clinical, clinical and post marketing activities. The work is concluded in close collaboration with the relevant groups at Affibody that are responsible for in-house upstream-, midstream- and downstream process development, assay development, and tech transfer to CMO:s and other service providers within the area.

The role is characterized by covering a wide spectrum of activities within CMC, as well as a deep understanding of the drug development process, including current good practices (cGxP).

The person suitable for this role has a strong interest in people management, performance reviews, continuous improvement of processes, and keeping up to date with the current regulatory frameworks guiding the drug development activities.

Head of CMC:

  • Is expected to lead the team of CMC Directors to support Affibody’s non-clinical, clinical, and post marketing activities
  • Responsible and accountable for overall CMC strategy, including: vendor identification and contracting, oversight of CMO perfomances; development and maintenance of plans and timelines; and budgets
  • Responsible and accountable for planning and coordinating the activities within the group, making sure that work is performed with quality and executed within specified timelines and budges
  • Responsible and accountable for complying with relevant cGxP frameworks
  • Responsible for ensuring that the group acquires sound knowledge in relevant areas that will elevate the level of knowledge within the CMC field and the current regulatory frameworks guiding the drug development activities

Qualifications 

Education

  • An advanced degree in Life Sciences

 Experiences

  • More than ten years of relevant experience in an industrial setting
  • Extensive experience from cGMP, DS, DP, and formulation work
  • Extensive experience from people management and in planning, directing, monitoring and coordinating teams
  • Experience from project management
  • Experience from out-sourcing of research activities
  • Experience from development of biologics
  • Experience from regulatory guidelines and compilation and reviewing of regulatory documentation

Skills and abilities

  • Strong interest in people management, and keeping up to date with the development of the field within the industry
  • Strong relationship and net-work building skills
  • Comfortable working in a dynamic environment in a growing organization, and in cross-functional teams
  • Good negotiation skills
  • Strong communication/interaction skills
  • High energy, driven, able to take initiative, result oriented and self-motivated

Application and more information

You are welcome with your application by e-mailing your CV and a personal letter to knut.nattochdag@aktivia.se as soon as possible. We are working continuously with this recruitment project. Write “Head of CMC” in the subject field. Please call Knut Natt och Dag on +46 722 166 800 if you have any questions. 

Affibody is cooperating with Aktivia Science Work in this recruitment. Aktivia Science Work is a recruiting company within Life Sciences specialized in positions within the pharmaceutical industry – from early discovery through pharmaceutical development and clinical development to the market place. www.aktivia.se

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