Munich, Germany
Job Description:
* Lead planning and oversee execution of upstream process development and characterization
studies including scale-up
* Lead internal material supply at laboratory and pilot scales
* Lead implementation and evaluation of new technologies in cell culture/fermentation
* Support cell culture/fermentation work outsourced to C(D)MOs
* Support technology transfer to C(D)MOs
* Collaborate with functions in cell line development, downstream processing, and material
supply
* Author and review technical documents, protocols, reports, summaries, batch records and
SOPs
* Monitor, evaluate, and maintain performance of upstream clinical manufacturing
* Prepare and review regulatory documents in sections related to USP
* Communicate management decisions and project updates to the relevant project team
meetings
* Identify, mitigate and if necessary, escalate project risks (quality, timeline, budget, scope) in
upstream process development and manufacturing
Your profile:
* Ph.D. in biochemical engineering, biochemistry, biotechnology, chemical engineering or a
related discipline with minimum of 2 years of industry-relevant experience, or M.Sc. in
biochemical engineering, biochemistry, biotechnology, chemical engineering or a related
discipline with minimum of 5 years of industry-relevant experiences
* Proficient with upstream operations such as cell culture/fermentation, media preparation,
and harvest
* Proficient with in-process analyses needed to evaluate cell culture and fermentation
performance
* Comprehensive understanding of cGxP requirements for clinical biopharmaceutical
manufacturing
* Experience in cell culture process development and process transfers in support of cGMP
manufacturing and technical trouble shooting
* Demonstrated organizational skills and the ability to successfully manage multiple technical
projects and priorities in a fast-paced environment
* Strong technical writing and verbal communication skills are required
* Proficiency in English is essential
* Desirable: proficiency in statistical analysis and related software
