Pieris Pharmaceuticals is a publicly traded biotechnology company (Nasdaq: PIRS) with operations in Germany and the United States, specializing in the discovery and development of anticalin-based drugs to address validated disease pathways individually and transformatively. Together with our partners, we carry out innovative research in the fields of immuno-oncology, respiratory diseases and ophthalmology. Pieris' proprietary Anticalin proteins are a novel class of drugs validated by clinical trials and partnerships with leading pharmaceutical companies.

To strengthen our team, we are looking for an experienced:

Biologics Downstream Process Specialist, CMC

Your Tasks:

  • Support process development, process fit analysis, technical transfer, scale-up and process validation at our CDMO sites.
  • Monitor, evaluate and maintain performance of downstream manufacturing at CDMOs. 
  • Maintain a strong working relationship with internal and external partners in the areas of trouble-shooting, technology review and new product manufacturing implementation.
  • 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 and SOPs.
  • Author / review CMC sections and reports supporting regulatory filing.
  • Lead investigation into any purification related deviations.
  • Prepare management decisions and communicates project updates to the relevant project governance meetings and steering committee.
  • Identify, mitigate and if necessary, escalate project risks (quality, timeline, budget, scope) in downstream process development and manufacturing.
  • Complete all required training.
  • Provide support for upstream process development as needed.

Our Requirements:

  • Ph.D. or M.Sc. in biochemistry, chemistry, biotechnology, biochemical engineering, or a related discipline with 2 - 6 years of related experiences.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing.
  • Experience in purification process development, process transfers, in support of cGMP manufacturing and technical trouble shooting.
  • Proficient with downstream operations such as centrifugation, filtration, chromatography, buffer preparation, cleaning and sanitization. Proficient with any in-process analysis needed to evaluate purification performance.
  • Experience in interfacing with health authorities on regulatory CMC filings and audits.
  • Demonstrated organizational skills and the ability to successfully manage multiple technical projects and priorities in a fast-paced environment.
  • Additional experience with USP is an advantage.
  • Strong technical writing and verbal communication skills are required.
  • Ability to travel is required.

We are a fast-growing biotechnology company with approximately 120 employees at our sites in Freising (Greater Munich Area) and Boston (USA). 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 directly in the success of the company through a stock option program and a stock savings plan. In addition, each employee participates in a bonus program based on the achievement of individual and company-wide goals. Creative employee events take place several times a year, as team spirit is essential for us. The joint creation of an innovative and participative corporate culture is an important concern for us.