CMC Project Manager Process Development and Manufacturing
Affibody AB is a clinical stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platform: Affibody® molecules and Albumod®.
Affibody is now looking to recruit an additional CMC project manager to the CMC group. The location is in Affibody’s premises at Karolinska Institutet Campus Solna. You would join a dynamic team in a caring, ambitious, and goal-oriented company with an exciting pipeline of projects based on our proprietary technology platform.
The CMC group leads the Chemistry, Manufacturing and Controls (CMC) aspects of the development projects at Affibody and holds scientific and technical knowledge for the process development, manufacturing, and analysis of our clinical products.
The role in general
The CMC project manager role involves the responsibility for strategies and oversight of internal and external activities related to process development, sourcing, process and analytical technology transfer, and managing external manufacturing and analysis of DS and DP. The role requires both operational management and strategic overview.
The work is led by CMC and carried out in close collaboration with functional groups at Affibody that are responsible for in-house DS and DP process development, protein characterization and assay development.
Depending on the person joining, the role will adapt to a focus on DS or DP development and manufacturing. As project manager for DS or DP process development and manufacturing your main responsibilities will include:
- Lead and be responsible for the CMC part of our development projects including planning project activities, budgeting, timelines and perform continuous risk assessment and mitigation
- Active participation in the governing project core team
- Provide scientific expertise and problem solving within your area of competence for DS and/or DP process development and manufacturing, and formulation development of biomolecules
- Coordinate and lead scouting and selection of external contract labs or contract manufacturing and lead outsourced activities related to CMC
- Manage CMC technology transfer and manufacturing at CMOs including the lead of deviation investigations, CAPA, and change control to assure compliance with GMP for manufacturing
- Keep up to date in quality- and regulatory requirements for biopharmaceutical DS and DP
- Write and/or review CMC related documents including process descriptions and protocols, applicable sections in registration files and changes to files, and internal and external SOPs
- University degree in Chemistry, Biotechnology and/or Process Engineering and a minimum of 10 years of experience in the pharmaceutical industry
- Experience of CMC, including formulation development and process characterization, preferably DP or DS upstream process development
- Experience and knowledge of technology transfers and cGMP manufacturing of biopharmaceuticals
- Experience of industry CMC regulatory standards
- Experience of cross functional teamwork and project management, including planning, directing, budget work, monitoring and coordinating the work within a project team
- Experience of scouting, coordinating and leading outsourcing activities involving direct contact with CROs and CMOs
- Excellent verbal and written communication skills in English and ability to communicate successfully in a business environment
To thrive in this role, you need to feel strong engagement for cross functional teamwork and coordination of activities delivering to reach business-critical goals. The role further requires in depth knowledge and interest in science related to process development, formulation and manufacturing, biopharmaceutical development in general, as well as an interest to keep up to date with the theoretical and practical development of the field within the industry.
To be successful in the role you need to be highly self-motivated, driven and comfortable working in a dynamic environment in a growing organization and in cross functional teams. You have skills to establish and maintain good collaboration with different parties, both externally and internally. You are passionate about coaching and supporting team members and you have the ability to prioritize activities to deliver critical goals in time.
We further believe you have capabilities to analyze complex information or situations to provide sound solutions and to identify, adapt and implement new technologies.
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 firstname.lastname@example.org. If you have any questions about the role, please contact Head of CMC, Susanne Wood at email@example.com.
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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)