Project Manager Process Development and Manufacturing

Affibody is looking to recruit a project manager for Drug Substance (DS) and Drug Product (DP) process development, formulation development, and manufacturing of biopharmaceuticals to the CMC group. The location is in Affibody’s premises at Karolinska Institutet Campus Solna.

The CMC group currently consists of six coworkers, and leads the Chemistry, Manufacturing and Controls (CMC) aspects of development projects, and performs continuous risk assessment and mitigation on DS and/or DP level. The CMC group furthermore holds scientific and technical knowledge for the manufacturing and analysis of our clinical products.

CMC project managers coordinate internal activities relating to process development and analysis, and are responsible for strategies and oversight of process development, sourcing, process technology transfer, and managing external manufacturing and analysis of DS and DP, including DS/DP release assays, formulation and compatibility testing for Affibody’s projects in clinical and commercial development, which also includes ownership and support for CMC regulatory file documentation for initial applications and further development to support commercial filings. The work is conducted in close collaboration with functional groups at Affibody that are responsible for in-house upstream-, midstream- and downstream process development, protein characterization and assay development.

The role in general

The person suitable for this role has a strong interest in cross functional team work, coordination of activities, delivering business critical goals in time, science related to process development, formulation, and manufacturing, biopharmaceutical development in general, and keeping up to date with the theoretical and practical development of the field within the industry.

As project manager for DS and DP process development and manufacturing your main responsibilities include:

  • Lead and provide scientific expertise of DS-, DP, and formulation development of biomolecules (in-house and out-sourced), including unit operations covering upstream-, midstream, and downstream process unit operations and/or peptide synthesis, formulation development, and analyses
  • Coordinate and lead outsourcing activities related to DS-, DP- and formulation development and manufacturing
  • Manage DS and DP technology transfer and manufacturing at CMO’s
  • Keep up to date in quality- and regulatory requirements for biopharmaceutical DS and DP
  • Write and/or review DS and DP process descriptions and protocols, applicable sections in registration files and variations, internal and external SOP´s
  • Lead deviation investigations, CAPA and change control

Qualifications

The right candidate fulfills the following qualifications:

  • University degree in Chemistry and/or Biotechnology and/or Process Engineering and a minimum of 10 years of experience in the pharmaceutical industry
  • Experience of DS- and DP process development, formulation development and process characterization
  • Experience and knowledge of DS- and DP manufacturing
  • Experience and knowledge of technology transfers and cGMP manufacturing of biologics
  • Experience of industry regulatory standards
  • Experience of cross functional team work and project management, including planning, directing, monitoring and coordinating the work within a project team, and budget work
  • Experience of coordinating and leading outsourcing activities involving direct contact with CROs and CMOs
  • Excellent verbal and written communication skills in English and ability to communicate in a business environment

Personal attributes

We are looking for a person with a strong interest for process development, formulation, and manufacturing, who is well up to date with the development of the field within the industry. To be successful in the role you need to be highly self-motivated and driven. You need to be comfortable working in a dynamic environment in a growing organization and in cross-functional teams, with strong team working skills to establish and maintain good collaboration with different parties both externally and internally. You have the ability to coach and support team members and to prioritize activities in order to deliver business critical goals in time.

You have capabilities to analyze complex information or situations to provide sound solutions and to identify, adapt and implement new technologies. The role requires both operational management and strategic overview.

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 hr@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)