Currently we are assisting a growing biopharmaceutical company that is expanding its activities to
meet patient need. As a result of the growth they are looking to add Process Manager Upstream
Development.
The company is working on Drug Substance production which utilizes both Stainless Steel and Single
Use Bioreactors.
Your tasks:
* Design of robust, scalable and economic upstream processes for a wide range of
biopharmaceuticals in line with clinical and commercial timelines and overall business plans
* Process scale up and transfer to our internal and external manufacturing sites
* Design of late stage development activities and process characterization studies in preparation
of process qualification and validation at manufacturing scale
* Assessment and implementation of new process technologies
These responsibilities will be assumed by actively carrying out and managing the following tasks:
* Direct communication and representation towards our customers in face-to-face meetings and
conference calls
* Interdisciplinary and cross-functional interaction with colleagues from associated departments
* Troubleshooting and process optimization at bench and manufacturing scale
* Participation in deviation, out-of-specification and change management
* Compilation and review of risk assessments, protocols and reports
* Ensuring compliance with international technological and regulatory standards
* Review of relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
* Participation in customer audits and authority inspections
* Involvement in process optimization and innovation projects
Your Profile:
* PhD or relevant experience in biotechnology, biochemistry or comparable scientific/technical
field
* Several years of active experience in the field of upstream processing using scalable
technologies in the context of biopharmaceutical manufacturing
* Strong and motivating communication skills, team spirit and flexibility
* High level of initiative and excellent organizing skills
* Entrepreneurial mindset, economic and analytical thinking
* Fluent in German and English
