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

Quality Control Manager (m/f/d)

Your Tasks

  • Provide oversight for GMP analytical activities (method qualification/validtaion and product release and stability testing for drug substance and drug product) at CMO/CRO sites.‬‬‬‬‬
  • Review and/or approve key QC/analytical documents (protocols, reports and data).
  • Track and trend stability data, and author stability reports for all programs.
  • Act as the primary QC/Analytical representative (and subject matter expert) for the CMC team and CMOs for assigned projects.
  • Collaborate within CMC teams to actively contribute to deliverables. Engage in team discussion on issue resolution.
  • Assist in building in-house Quality Control processes:Writing and reviewing Standard Operating Procedures.
  • Write/review/approve in-house and external quality documents (change control, CAPA, deviation reports etc).
  • Provide support for preparation of CMC sections for regulatory filings (e.g. IND/CTA, IMPD, Investigator’s Brochure, CTD, etc.).‬ ‬‬‬‬‬‬‬‬‬‬

Our Requirements

  • BS./MS in Life Sciences with ‪10 years of experience in the pharma/biotechnology industry or Ph.D. with appropriate experience.‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
  • In depth knowledge and experience in methods used for BioPharmaceuticals method qualification/validation, transfer and managing lifecycle of analytical methods (e.g. HPLC, Gel and Capillary Electrophoresis, compendial methods, ELISAs, etc.).
  • Experience in QC release and stability testing for protein therapeutics.
  • Experience working with CROs and CMOs. ‬‬‬‬‬‬‬‬‬‬‬‬‬‬‬
  • ‪Working knowledge of cGMPs as well as FDA, EMA, USP/PhEur and ICH guidelines.‬‬‬‬‬‬‬‬‬‬‬‬‬‬
  • Broad knowledge/experience in biopharmaceutical process development and manufacturing.
  • Demonstrated organizational skills, attention to details and the ability to successfully manage multiple technical projects and priorities in a fast-paced -collaborative environment.
  • Strong technical writing and verbal communication skills are required.
  • Ability to travel occasionally is required.
 
We are a fast-growing biotechnology company with approximately 120 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 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.