Project Manager Analysis and Characterization, CMC

Affibody is looking to recruit a project manager for analysis and characterization to our CMC group. The location is at our newly established premises in Solna.

The CMC group holds scientific and technical knowledge for the manufacturing and analysis of our clinical products and is responsible for outsourcing activities for manufacturing and analysis. The CMC group is further responsible for strategies and oversight of process development, sourcing and managing external manufacturing and analysis of Drug Substance and Drug Product for Affibody’s projects in clinical and commercial development.

The role in general

As project manager for analysis and characterization in the CMC group your main responsibilities include:

  • Coordination of analysis and characterization of biomolecules (in-house and out-sourced) during process development
  • Coordination of outsourcing activities for analysis and characterization
  • Lead and scientific expert in tech transfers of analytical methods, comparability and stability studies
  • Scientific expert in qualification and validations of analytical methods
  • Process owner and lead of analytical and characterization matters in deviation investigations, CAPA and change control
  • Be up to date in quality and regulatory requirements for biopharmaceutical products
  • Write and/or review analytical method descriptions and protocols, applicable sections in registration files and variations, internal and external SOP´s, qualifications and validations of analytical methods.

Qualifications

The right candidate fulfills the following qualifications:

  • University degree in Chemistry and/or Biotechnology and/or Process Engineering and a minimum of 5 years of experience in the pharmaceutical industry
  • Experience of project management and cross functional team work
  • Experience of analysis and characterization of Drug Substance and Drug Product during development and manufacturing
  • Experience and deep knowledge of analytical and characterization method development
  • Experience of technology transfers and comparability studies
  • Experience of qualification and validation of analytical methods
  • Experience of cGMP in manufacturing of biopharmaceuticals and industry regulatory standards
  • Excellent verbal and written communication skills in English and ability to communicate in a business environment
  • Previous work involving direct contact with CRO’s and CMO´s

Personal attributes

To be successful in the role you need to be highly self-motivated and driven. You need to have the ability to collaborate and strong team working skills to establish and maintain good collaboration with different parties both external and internal. You have capabilities to analyze complex information or situations and provide sound solutions and to identify, adapt and implement new technologies. The role requires both operational management and strategic overview. You have the ability to work independently and to make priorities in order to deliver business critical items in time.

Application

We will interview candidates continuously and welcome your application today!

Please send your application (CV and a note on why you think this is your next step) to johanna.krejby@affibody.se. If you have any questions about the role, please contact Head of CMC, Susanne Wood, at susanne.wood@affibody.se.

Affibody in short

Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

Upcoming reports Financial calendar

  • Interim Report January to March 2020 (May 15, 2020)
  • Interim Report January to June 2020 (August 21, 2020)
  • Interim Report January to September 2020 (November 13, 2020)
  • Year End Report 2020 (February 2021)