Quality Control Manager (m/f/d)

  • Pieris Pharmaceuticals GmbH
  • Work experience
  • Quality Management, Quality Assurance
  • Fulltime
  • Published: 2020-12-22
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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 Quality Control Manager with experience in analytical sciences, preferably in the area of large molecules. Suitable candidates will combine broad technical understanding of protein manufacturing and analytics, experience in CMC regulatory and QC project management skills.

 

Your Tasks

  • Management of GMP QC activities (method qualification/validation and product release and stability testing for drug substance and drug product) at CMO/CRO sites.
  • Act as QC subject matter expert for the CMC team and CMOs for assigned projects. Engage in team discussion on issue resolution.
  • Review and/or approve key QC/analytical documents (protocols, reports and data).
  • Track and trend stability data, author stability reports for all programs.
  • Author and review Standard Operating Procedures.
  • Manage in-house and external quality events (change control, CAPA, deviation reports, etc.).
  • Provide support for preparation of CMC sections for international regulatory filings.
  • Support in establishing internal QC laboratory.

Our Requirements

  • Bachelor's / Master's degree in Life Sciences with 3 years of experience in the pharma/biotechnology industry or Ph.D. with appropriate experience
  • In-depth knowledge and experience with methods used for Biopharmaceuticals. Experience with method qualification/validation and transfer (e.g. HPLC, Gel and Capillary Electrophoresis, compendial methods, ELISA)
  • Experience in QC release and stability testing for protein therapeutics.
  • Experience working with CROs and CMOs would be beneficial
  • Knowledge of biopharmaceutical processes would be helpful.
  • 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

Zeppelinstra├če 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
  • Ms. Ines Lehmann