Team Lead (m/f/d), Downstream Process (DSP) Development

  • Pieris Pharmaceuticals GmbH
  • Hallbergmoos
  • Research, development, teaching
  • Fulltime
  • Published: 2020-04-06
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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

  • Subject Matter Expert (SME) for all DSP-related topics over multiple projects in different stage of development    
  • Oversight of DSP development, process fit analysis, technical transfer, scale-up and cGMP manufacturing at our C(D)MO sites. 
  • Maintain a strong working relationship with internal and external partners in the areas of troubleshooting, technology review and new product manufacturing implementation. 
  • Technical and scientific supervision of laboratory-based staff. 
  • Establishment and coordination of DSP-focused “Developability” assessment of pre-clinical Anticalin-based candidates.  
  • Maintain keen technical familiarity with process and process equipment, process optimization evolution, and technical problem solving. 
  • Author and review technical documents, protocols, reports, summaries, batch records, SOPs and regulatory documents. 
  • Prepare management decisions and communicate project updates to the relevant project governance meetings and steering committee as well as identify, mitigate and if necessary, escalate project risks (quality, timeline, budget, scope) in downstream process development and manufacturing

Our Requirements

  • Ph.D in biochemistry,Chemistry, biotechnology, biochemical engineering, or a related discipline
  • 3 - 6 years of relevant industry experience. 
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing. 
  • Experience in purification process development, process transfers, cGMP manufacturing and technical troubleshooting. 
  • Proficient with downstream operations such as centrifugation, filtration, chromatography, buffer preparation, cleaning and sanitization as well as any in-process analysis needed to evaluate purification performance. 
  • Experience in interfacing with health authorities on CMC filings and audits. 
  • Demonstrated people management skills as well as 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. 
  • Ability to travel is required. 

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

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