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

  • Pieris Pharmaceuticals GmbH
  • Hallbergmoos
  • Work experience
  • Project Management, Product Management
  • Research, development, teaching
  • Fulltime
  • Published: 2020-09-22
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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.
 

Your Tasks

  • 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.
     

Our Requirements

  • 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.
 
 

How to reach us

Zeppelinstra├če 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
  • HR Specialist
  • Ms. Ines Lehmann