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:

Senior Specialist GMP Quality Assurance (m/f/d)

Your Tasks

  • Conduct product release activities for master cell banks, drug substance, drug product, and the IMP for all phases of clinical development including review and approval of master batch records and executed batch records.
  • Partner with CMC Operations, Technical Development, Quality Control and Supply Chain departments within the company to assess overall product quality performance, including the identification of any product-specific quality and compliance risks, and develop mitigation plans using appropriate risk-based approaches.
  • Actively collaborate with CMOs and contract testing organizations (CTOs) to initiate, investigate, and resolve deviations and investigations prior to lot disposition.
  • Participate in supplier audits of CMOs and CTOs.
  • Review temperature excursions related to IMP and GMP material shipments.
  • Manage and address deviations, investigations, corrective and preventive actions (CAPAs), change controls, compliance council meetings, material review boards, out of specification (OOS) findings, and similar developments.
  • Generate quality metrics, assesses the results in collaboration with CMC Operations, develops CAPAs with supplier and vendor quality units and reports results to management.
  • Ensure compliance with CMO and CTO quality agreements.
  • Support internal and external cGMP audit plans for the company’s clinical development programs.
  • Assist in preparing or reviewing CMC sections of regulatory submissions.
  • Represent the QA department on research and development project teams.
  • Actively participate in audits and inspection readiness activities.
  • Domestic and international travel required (approximately 20%).

Our Requirements

  • Bachelor’s degree in biology, chemistry, or other life-sciences related field.
  • 5+ years direct QA experience in a cGMP manufacturing environment.
  • Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical development and operations.
  • Strong team player with flexible and positive attitude.
  • Strong attention to detail and critical thinking ability.
  • Exercises judgment within broadly-defined practices and policies in determining solutions and actions.
  • Demonstrates ability to identify and recognize critical decisions that will result in potential delays in schedule or operations or that may jeopardize overall clinical and business activities.
  • Knowledge of drug substance, drug product manufacturing principles, equipment and processes.
  • Experience working in a virtual environment with CMOs preferred.
  • Demonstrated strong understanding of US cGMPs and knowledge of EU GMPs.
  • Experience in the following is highly desirable:
    • Drug substance and drug product operations
    • IMP distribution/supply chain logistics
    • Technology transfer, scale-up and late phase clinical development, as well as commercial GMP drug release
 
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 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.