Downstream Processing Scientist

Description

Rentschler Biopharma ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) für Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lösungen für die Bioprozessentwicklung und die Herstellung hochwertiger Biopharmazeutika sowie damit verbundene Beratungsleistungen einschließlich Projektplanung und regulatorischer Unterstützung an. In Stevenage, UK, haben wir das auf Zell- und Gentherapie spezialisierte Unternehmen Rentschler ATMP Ltd. gegründet. Wir sind ein Familienunternehmen mit rund 1100 Mitarbeiter/-innen aus 25 Nationen. Was uns bei Rentschler Biopharma vereint, ist die Leidenschaft für das, was wir tun. Wir versetzen unsere Partner in die Lage, Patienten mit schweren oder seltenen Erkrankungen zu helfen. Mit unserer Hingabe und unserem Wissen wandeln wir medizinische Forschung in ausgezeichnete Biopharmazeutika um. So leisten wir einen entscheidenden Beitrag zur weltweiten Verfügbarkeit essenzieller Therapien. Um unser langfristiges und nachhaltiges Wachstum zu sichern, bauen wir unser Team weiter aus. Werden Sie Teil unseres einzigartigen Teams und gestalten Sie mit uns gemeinsam die Zukunft der Biopharma-Branche! Tasks and Responsibilities

• Coordinate/plan/execute the delivery of downstream process development programs for customer gene therapy products.
• Perform end to end DSP development activities from lab to pilot scale (Buffer Preparations, Filtration, Chromatography, TFF….) under line manager / client requirements.
• Writing / adapting all relevant DSP documents (e.g. process descriptions, protocols, reports).
• Completing technical transfers from clients to PD and further into GMP.
• Provide technical and project specific support to address customer queries and project updates.
• Identify and escalate issues as they occur, troubleshoot issues through technical expertise, and report accordingly with all relevant information.
• Act as a DSP equipment owner, troubleshoot issues, and ensure equipment is serviced and fully operational in support of lab management activities.
• Support GMP operations and other departmental functions (procurement, commissioning, qualification, validation and safety) as required.

• Degree in Life Sciences or Biological / Chemical / Biochemical Engineering or higher qualification.
• Industry experience with relevant biopharmaceuticals roles within the area of DSP (1-4 years depending on qualification and experience).
• Technical and practical understanding of DSP unit operations (filtration, chromatography and TFF) and their optimization and scaling.
• Awareness of viral vector bioprocessing challenges, current state of art, and future industrial trends.
• Experience of lab to pilot scale bioprocessing equipment, including single use equipment, and their consumables.
• Capable of experiment execution, reporting, and design.
• Awareness of industry GMP manufacturing standards for GMP compliant scalable processes.
• Good organizational and communication skills, experienced in liaising with internal and external stakeholders providing a credible interface as a technical SME.
• Team player able to energise and motivate the team.

• Work in a company that offers real added value and manufactures medicines for seriously ill patients.
• To be part of the ATMP growth and success story, participating in the development of a great company culture based on teamwork, empowerment and opportunity for personal growth.
• A holiday entitlement of 28 days plus UK Bank Holidays.
• Flexible working conditions, including mix of work from home and office and adjustable start/finish times.
• An above market pension provision starting at 5% employer contribution and increasing with length of service.
• Private medical health care and benefits scheme.
• Plus additional benefits.