Chemist, Biochemist, Chemical Engineer as CMC Project Manager (m/f/d)

 PIERIS Pharmaceuticals GmbH  Freising bei München
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.

As the Pieris’ pipeline continues to advance, the described CMC activities will become increasingly complex, time critical and thus a core part of the business. This is why we are looking for candidates that will combine broad technical understanding of protein manufacturing and analytics, experience in CMC regulatory with excellent project management skills.

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

CMC Project Manager (m/f/d)

Your Tasks:

  • Building and maintaining a productive relationship with internal Departments, external CMOs as well as with Pieris’ collaborator and partner networks.
  • Development, communication and monitoring of project-related budgets, timelines and risks
  • Ensure deliverables are met according to Corporate goals and Pieris values
  • Lead the decision-making and risk-management process
  • Coordination of filing activities within the CMC team and with contributing parties
  • Support BD with verification of final proposals and input on manufacturability and cost of in-licensing candidates
  • Responsibility for project documentation (project charter, project reports etc.)

Our Requirements:

  • M.Sc. or Ph.D. in chemistry, biochemistry, chemical engineering or related disciplines
  • 5+ years of relevant industry experience as Project or CMC Manager
  • Experience in process development, technical transfers, support of cGMP manufacturing and technical trouble shooting for clinical and commercial biopharmaceutical manufacturing
  • Experience in interfacing with health authorities on CMC filings and audits
  • Ability to successfully manage multiple technical projects and priorities in a fast-paced environment.
  • Excellent communication, technical writing skills and a global mindset are essential for this role
  • Experience with MS Project, Excel, SharePoint and EDMS
  • Background in formulation or fill and finish of biologics are a plus

 

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 (from January 2020) 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.

 

Apply now!

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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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