Project Manager (m/f/d), CMC

  • Pieris Pharmaceuticals GmbH
  • Research, development, teaching
  • Fulltime
  • Published: 2020-08-25
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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

  • 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

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 Project Manager
  • Ms. Cathrin Grolig