Head of Protein Expression
Affibody is looking to recruit a Head of the Protein Expression group. The location is at our newly established premises in Solna.
The Protein Expression group currently consists of 5 employees and is scientifically and technically responsible for the upstream- and midstream steps in the biopharmaceutical manufacturing of Affibody® molecules, including responsibility for supporting the internal research process with development of new Affibody® molecule candidate drugs and process development of upstream- and midstream steps, and in-process analyses. The group supports with subject matter expert competence in tech transfer to contract manufacturing organizations (CMOs), for scale-up, process optimization, manufacture and supply of Drug Substance (DS) for Affibody’s projects in non-clinical-, clinical-, and commercial development. The work is conducted in close collaboration with the CMC group and other relevant groups at Affibody that are involved in the internal research process and manufacturing of DS.
The role is characterized by covering several technologies, methods and in-process assays within recombinant protein production of biopharmaceuticals, as well as a deep understanding of the drug development process, including cGMP.
The person suitable for this role has a strong interest in people management and leadership, science in general, continuous process improvement, and keeping up to date with the theoretical and practical development of the field and the current regulatory frameworks guiding the drug development activities.
The role in general
As Head of Protein Expression, you will lead the Protein Expression group and your main responsibilities include:
- Lead the Protein Expression group within the field of microbial fermentation and product recovery, including adjacent in-process controls
- Responsible and accountable for overall planning, directing, monitoring and coordinating the research and development within the group, making sure that work is performed with quality and executed within specified timelines
- Responsible and accountable for all work environment aspects involving the Protein Expression group
- Responsible for all infrastructure aspects involving the Protein Expression group, e.g. writing and/or reviewing SOPs
- Responsible for that the group acquires sound knowledge in relevant areas that will elevate the level of knowledge in the company concerning methodological and technological developments within the field of expertise and the current regulatory frameworks guiding the drug development activities
- Responsible for assuring that the Protein Expression group works with continuous improvement of the internal research process in alignment with the other research groups at Affibody
- Support with subject matter expertise in tech transfer of processes (upstream/midstream), in-process methods, and/or other analytical methods to CMOs and other service providers within the area
- Write and/or review process descriptions and protocols, applicable sections in registration files and variations, internal and external SOP’s, qualifications and validations of methods
- Contribute in deviation investigations, CAPA and change control
- Keep up to date with quality and regulatory requirements for biopharmaceutical products
The right candidate fulfills the following qualifications:
- An advanced degree in Life Sciences or Engineering Sciences, ideally within the field of microbial fermentation technology, and a minimum of 10 years of experience of drug development in an industrial setting
- Extensive experience of people management, and in planning, directing, monitoring and coordinating the work within a team
- Experience of cross functional team work
- Experience of upstream- and midstream process development, both theoretically and practically
- Experience of development of biologics
- Experience of technology transfers involving direct contact with CMOs and CROs
- Experience of process validation
- 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
To be successful in the role you need to have a strong interest in people management, and keeping up to date with the development of the field within the industry. You have the ability to coach and support team members, coordinate resources, and to prioritize activities in order to deliver business critical goals in time. 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. You have an interest for practical laboratory work, continuous improvement of processes, and can adapt and implement new technologies. You need to be driven, able to take initiative, results oriented and self-motivated. The role requires both operational management and strategic overview.
We will interview candidates continuously and welcome your application today! Please send your application to email@example.com. If you have any questions about the role, please contact SVP Research Operations, Karin Nord at firstname.lastname@example.org.
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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)