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:

Analytical Development Specialist, CMC

The main task of this position is to serve as subject matter expert for analytical development activities that support process development and clinical manufacturing for products in Pieris’s Pipeline.
 

Your Tasks:

Included, but not limited to, are:
  • Serve as analytical Subject Matter Expert for assigned projects.
  • Working closely with the CMC project manager and Head of Quality Control / Analytical Development, establish method development / characterization strategy for projects entering clinical development stage.
  • Working closely with the Bioanalytics and Protein Analytics group and CMC project management, provide oversight for method transfer, development and characterization activities at CMO/CROs.
  • Provide support / oversight for method qualification, validation, specification development, GMP manufacturing, product release and stability testing and troubleshooting and investigations.
  • Collaborate within CMC team members to actively contribute to deliverables. Engage in team discussion on issue resolution.
  • Author, review or edit technical reports and sections for regulatory filing.

Our Requirements:

  • Ph.D. in Analytical Chemistry, Biochemistry, Molecular and Cellular Biology or a related discipline with two or more years of industry experience, or master’s degree with more than 7 years of relevant industry experience.
  • Hands-on and industrial experience with analytical method development and qualification for biologics products development.
  • Hands on experience in protein structural characterization.
  • Thorough knowledge of analytical methodologies applied to biopharmaceuticals.
  • Broad knowledge / experience in biopharmaceutical process development, technical transfer and manufacturing.
  • Understanding of cGMP requirements for clinical and commercial products manufacturing.
  • Demonstrated organizational skills, attention to details 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 occasionally is required.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
 
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.