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.

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

Head of Quality Control (m/w/d)

Your Tasks

  • Promote a culture of total quality and operational excellence including proposing quality improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies
  • Demonstrate technical proficiency in analytical methodology and adherence to GMP and ICH compliance
  • Representation of QC function internally as well as in Pieris’ alliances and collaborations
  • Help to further expand and support the QC team
  • Setting up the Quality control function, building up processes, workflows and strategies (stability, DS/DP release etc.) together with QC documentation system
  • Mid- and long-term objectives, in-sourcing the critical activities from Contract Testing Laboratories (CTLs) /CMOs and setup the QC lab in our new facility in Halbergmoos with a strong focus on GxP processes
  • Manage in-process, release, and stability testing of drug substance (DS) and drug product (DP) at CMOs andCTLs as well as maintain stability trending databases and oversight of active studies
  • Oversee method transfer, qualification, and validation at CTLs and CMOs
    Compile and review (raw) data to perform trending analysis for method performance and controls
  • Provide QC oversight and approval of cGMP QC documents (e.g., change controls, deviations, CAPAs, methods, validation protocols, OOS, OOT, etc.) both internally as well as at contract sites
  • Review and approve protocols and reports such as Method Validation, Method Transfer, Process Validation and Stability
  • Manage reference standard and stability programs for clinical products
    Maintain product specifications including proposal of new and/or revised specifications
  • Author QC sections (e.g., batch analysis, analytical methods, reference standard, stability) of regulatory filings (CTD, NDA, BLA or IND) and contribute to appropriate sections of Annual Product Review
  • Serve as an SME for areas of responsibility during regulatory inspections and participate in cGMP audits of CTLs
  • Keep abreast of industry developments including new technology and forthcoming regulations

Our Requirements

  • University Degree in Life Sciences, Pharmacy, Chemical Engineering or Bioengineering
  • 5+ years of relevant (industrial) experience in QC role
  • Several years professional experience in a GMP regulated environment with a proven track record in biotech or pharmaceutical industry is required
  • Knowledge of biopharmaceutical manufacturing large scale processes is beneficial
  • A strong technical background in analytical methods (capillary techniques, HPLC, ELISA and other bioassay formats, mass spectrometry etc.)
  • Expertise in Analytical Method Development, Analytical Method Validation and Statistical Quality Control
  • An excellent knowledge of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation
  • Clear commitment to work in the highly regulated area of pharmaceutical development and to represent QC in cross-disciplinary working groups
  • Highly motivated and open-minded team player with well-developed interpersonal abilities, excellent communication as well as proven leadership skills
  • Strong strategic thinking and planning abilities
    Sound knowledge of Microsoft Office and other relevant applications
  • Strong verbal and written communications skill
    Fluent in written and verbal business English

 
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.