Drug Product Manufacturing Manager (m/f/d)

  • Pieris Pharmaceuticals GmbH
  • Work experience
  • Research, development, teaching
  • Fulltime
  • Published: 01.03.2021
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Pieris Pharmaceuticals (Nasdaq: PIRS) is a clinical-stage biotechnology company with operations in Germany and the United States. Pieris 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. It is our mission to develop life-changing therapeutic proteins for patients suffering from cancer and respiratory  diseases through the innovative application of novel science and cutting-edge technologies.

Our vision at Pieris is to build a fully integrated and fully digital research and development engine to translate Anticalin® and bi-specific antibody sciences into new treatments. Building a new data infrastructure and state-of-the-art data sciences is a top priority at our company today. As the Pieris pipeline continues to advance, we are looking for a highly motivated and committed Drug Product expert with a focus on the large molecules. Suitable candidates will combine broad technical understanding of protein manufacturing, formulation and analytics, experience in CMC regulatory and project management skills. 

 

Your Tasks

  • Drive technical Drug Product (DP) development and manufacturing activities at external C(D)MOs together with internal experts (from e.g. Quality Control, CMC Project Management, Supply Chain etc.).
  • Act as DP Subject Matter Expert in the internal project CMC teams and CMO interactions for assigned projects. Engage in team discussion on issue resolution.
  • Review and/or approve key DP manufacturing documents (development protocols, and reports, manufacturing batch records).
  • Support quality documentation (change control, CAPA, deviation reports etc.) and lead deviation investigations with regard to DP.
  • Support preparation of CMC sections for international regulatory filings (e.g. DP part of INDs, IMPDs).
  • Support formulation development from a manufacturing perspective and give strategic advice for phase appropriate DP presentations.
  • Support CDMO selections and process transfers to new CDMOs in the DP manufacturing area.
  • Support the establishment of phase appropriate shelf-life strategies.

Our Requirements

  • Bachelor's / Master's degree in Life Sciences with 5 years of experience in the pharma/biotechnology industry, or Ph.D. with appropriate experience.
  • In-depth knowledge and experience in Drug Product development and manufacturing for biologicals (preferably proteins) is a must.
  • Good understanding of product quality characteristics of therapeutic proteins.
  • Preferably, experience managing external DP CDMOs.
  • Demonstrated organizational skills and the ability to manage technical projects in collaborative environment.
  • Strong technical writing and verbal communication skills in English language are required.

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
  • Frau Ines Lehmann
  • HR Specialist