Pieris Pharmaceuticals is a publicly traded biotechnology company (Nasdaq: PIRS) with operations in Germany and the United States, specializing in the discovery and development of anticalin-based drugs to address validated disease pathways individually and transformatively. Together with our partners, we carry out innovative research in the fields of immuno-oncology, respiratory diseases and ophthalmology. Pieris' proprietary Anticalin proteins are a novel class of drugs validated by clinical trials and partnerships with leading pharmaceutical companies.
We are looking for an
Analytical Quality Control Manager
Reporting into the Director of Quality Control / Analytical Development, the ideal candidate will have a strong background in analytical / bio-chemistry and experience in analytical development and quality control activities for protein therapeutics in clinical stage. The major responsibility of the manager is to provide oversight / support for GMP analytical and quality control activities at CMOs to support clinical products manufacturing.
- Provide oversight for GMP analytical activities (method qualification/validation 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 and 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.)
- 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 directly in the success of the company through a stock option program and a stock savings plan. In addition, each employee participates in a bonus program based on the achievement of individual and company-wide goals. 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.