Scientist (m/f/d), Upstream Process (USP) Development

Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.
 

• 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.
   

• 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.
   

Pieris is a fast-growing biotechnology company with approximately 130 employees across our sites in Munich, Germany and Boston, United States. We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of our company goals. In addition, we offer each employee the opportunity to participate in a stock purchase plan as well as a stock option program that allows Pieris employees to benefit directly from the our success.
 
Numerous social benefits such as an additional employer-financed company health insurance, free drinks etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in both of our locations round off our overall package. Creative employee events take place several times a year, as we believe that a healthy spirit of collaboration is key to our success.
 
 

Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0