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.
To strengthen our team, we are looking for an experienced:
Biologics Downstream Process Specialist (m/f/d), CMC
- Support process development, process fit analysis, technical transfer, scale-up and cGMP manufacturing at our CDMO sites.
- Maintain a strong working relationship with internal and external partners in the areas of trouble-shooting, technology review and new product manufacturing implementation.
- Prepare management decisions and communicate project updates to the relevant project governance meetings and steering committee.
- Lead investigation into any purification related deviations.
- Identify, mitigate and escalate project risks in downstream process development and manufacturing.
- Author and review reports and technical documents supporting regulatory filing.
- Ph.D. or M.Sc. in biochemistry, chemistry, biotechnology, biochemical engineering or a related discipline in life-science.
- 4+ years of experience in downstream processing within the biopharmaceutical industry.
- Comprehensive understanding and experience with Good Manufacturing Practices (cGMP)
- Experience in purification process development, process transfers, in support of cGMP manufacturing and technical trouble shooting.
- Proficient with downstream operations such as centrifugation, filtration, chromatography, buffer preparation, cleaning and sanitization and any in-process analysis needed to evaluate purification performance.
- Experience in interfacing with health authorities on regulatory CMC filings and audits.
- Additional experience with USP is an advantage.
- Team player with highly structured approach and well-developed communication skills
- Ability to travel 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. 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.