Chemist, Biochemist as Analytical Development Manager - CMC, GMP (m/f/d)

 PIERIS Pharmaceuticals GmbH  Freising bei München
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 Manager (m/f/d), CMC

Your Tasks:

  • Provide oversight for analytical method transfer, development and qualification activities to support GMP manufacturing at CMO/CROs.
  • Ensure phase appropriate readiness of release and stability test methods for drug substance and drug product.  
  • Collaborate with internal partners to guide phase appropriate product characterization.  
  • Provide technical support for method troubleshooting and investigations.
  • Maintain a strong working relationship with internal and external partners in the areas of technology review and new methodology implementation. 
  • Author, review or edit technical reports and sections for regulatory filing. 

Our Requirements:

  • Ph.D. or M. Sc. in Analytical Chemistry, Biochemistry, or a related life-science discipline.
  • 4+ years of industrial experience with analytical method development and characterization for biologics products development (7+ years with M.Sc). 
  • Understanding of cGMP requirements for clinical and commercial products manufacturing. 
  • Ability to successfully manage multiple technical projects and priorities in a fast-paced environment. 
  • Ability to travel occasionally is required. 
  • Strong interpersonal skills including verbal and written communication are essential.

 

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 in a bonus program based on the achievement of individual and company-wide goals. In addition, we offer each employee the opportunity to participate in a stock savings plan and a stock option program that allows employees to benefit directly from the company's success. Numerous social benefits such as additional employer-financed company health insurance, free drinks, fruit baskets, etc. round off our overall package. 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.

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About PIERIS Pharmaceuticals GmbH

Pieris Pharmaceuticals GmbH is a subsidiary of Pieris Pharmaceutical Inc., a public US company. Pieris Pharmaceuticals GmbHis a clinical-stage biotechnology company advancing its proprietary Anticalin® technology to create differentiated drugs that are safer and more effective than conventional approaches. Exclusive to Pieris, Anticalin proteins promise to address high-unmet medical needs and...

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