Head of Upstream Process Development
Head of Upstream Process Development (m/f/d)
Original-Inserat anzeigenHead of Upstream Process Development (m/f/d) Permanent employee, Full-time · Hallbergmoos Pieris Pharmaceuticals (Nasdaq: PIRS) is a clinical-stage biotechnology company with operations in Germany and the United States. Pieris discovers and develops 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 and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. It is our mission to develop life-changing therapeutic proteins for patients suffering from cancer and respiratory diseases through the innovative application of novel science and cutting-edge technologies. Your Responsibilities Technical and scientific lead (subject matter expert, SME) for cell line development and upstream process development over multiple projects in different stages of development Coordination and oversight of activities outsourced to C(D)MOs including: Cell line development and cell banking Cell culture and fermentation process development and optimization Technical transfer to and between C(D)MOs Process scale-up Manufacturing Process validation Technical and scientific supervision of laboratory-based staff and coordination of external experts and contributors Authoring and review of technical and scientific documents such as protocols, reports, summaries, SOPs, manufacturing batch records, presentations, and scientific publications Preparation and review CMC documentation and relevant sections in regulatory filings Leading investigations into deviations in upstream processing activities under GxP, prepare risk assessments and CAPAs, and contribute to the change control process Maintain a strong working relationship with internal and external partners in the areas of troubleshooting, technology review and new product manufacturing implementation Support establishment and optimization of internal material production platforms for discovery and pre-clinical material supply Prepare management decisions and communicate project updates to the relevant project governance meetings and steering committee as well as identify, mitigate and if necessary, escalate project risks (quality, timeline, budget, scope) in downstream process development and manufacturing Build and maintain knowledge of current trends and emerging technologies for cell line development and upstream process development Our Requirements Ph.D. in biochemical engineering, biochemistry, biotechnology or a related discipline with at best more than five years of industry-relevant experience, or M.Sc. in biochemical engineering, biochemistry, biotechnology or a related discipline with at best more than ten years of industry-relevant experiences Proficiency in upstream operations such as cell culture, fermentation, media preparation and harvest Solid understanding of in-process analyses needed to evaluate process performance Profound knowledge in cell line development, upstream process development and industrial bioprocessing of engineered therapeutic proteins Comprehensive understanding of cGxP requirements for clinical biopharmaceutical manufacturing Experience in building relationships and working with C(D)MOs Experience in cell culture process development and process transfers in support of cGMP manufacturing and technicaltrouble shooting Experience in preparing CMC documentation for regulatory submissions Demonstrated organizational skills and the ability to successfully manage multiple technical projects and priorities in a fast-paced environment Why us? We are a fast-growing biotechnology company with about 150 employees in Hallbergmoos (Munich area) and Boston (USA). We are working in flat hierarchies with short decision-making processes and offer a working environment that is characterized by collaboration and innovation. Individual development is an important matter to us, which is why we offer tailor-made training programs. In addition to a basic salary at a competitive level, our employees participate in an attractive bonus program based on the achievement of our corporate goals, as well as in our stock option program. In addition, we offer numerous special benefits, such as health insurance and a contribution to the company pension scheme. By providing a bright, friendly and state-of-the-art working environment in the Science / Innovations Hub with excellent technical equipment, state-of-the-art laboratories and a Pieris restaurant, we aim to foster a great on-site working environment. A good work-life balance is very important to us at Pieris, so we make sure that family and well-being is a priority. We offer sufficient flexibility both in terms of working schedules and different lifestyles. Contact If you are interested in working in an exciting environment and would like to become part of our team, we welcome you to upload your application documents directly online. If you have any further questions, please contact us via
recruiting@pieris.com
. For further information please visit our homepage
www.pieris.com
. We are looking forward to reviewing your application! How to reach us Hallbergmoos (Germany) Pieris Pharmaceuticals GmbH Zeppelinstraße 3 85399 Hallbergmoos +49 811 12447-0 Boston (USA) Pieris Pharmaceuticals, Inc. 255 State Street, 9th floor Boston, MA 02109 +1 857 246-8998 Thomas Schwarzbauer Talent Acquisition Manager +49 174 214-0851
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Head of Upstream Process Development (m/f/d)
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Pieris Pharmaceuticals GmbH
Hallbergmoos
Einstiegsposition
Veröffentlicht am 08.01.2023
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