Project Manager (m/f/d), CMC

  • Pieris Pharmaceuticals GmbH
  • Research, development, teaching
  • Fulltime
  • Published: 25.08.2020

Pieris Pharmaceuticals (Nasdaq: PIRS) is a publicly-traded, clinical-stage biotechnology company with operations in Germany and the United States. Pieris specializes in the discovery and development of 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, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.

Your Tasks

  • Leading CMC teams across all functions including process development, formulation development, analytics, manufacturing, and QC
  • Building and maintaining a productive relationship with internal Departments, external CMOs as well as with Pieris’ collaborator and partner networks.
  • Managing and monitoring of CMC project budgets
  • Monitoring timelines and communicating risks and risk mitigation plans
  • Ensure deliverables are met according to project plans
  • Coordination of filing activities within the CMC team
  • Responsibility for project documentation (project charter, project reports etc.)

Our Requirements

  • M.Sc. or Ph.D. in biotechnology, biochemistry, chemical engineering, or related disciplines
  • 3 - 5 years of relevant industry experience in developing biologics being responsible for CMC disciplines such as process and formulation development or analytics
  • Experience in tech-transfers of biologics manufacturing processes, cGMP, regulatory guidelines for biologics and technical trouble shooting
  • Experience in interacting with health authorities on CMC filings and audits
  • Ability to successfully manage multiple technical projects and priorities in a fast-paced environment.
  • Excellent communication and technical writing skills combined with a global mindset are essential for this role
  • Experience with MS Project, Excel, SharePoint and EDMS

We are a fast-growing biotechnology company with approximately 130 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. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in our new company building in Hallbergmoos 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.

How to reach us

Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
  • HR Project Manager
  • Frau Cathrin Grolig