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!
What you will be responsible for:
- Coordinate and execute the delivery of GMP and engineering batches for customer gene therapy programs. Responsible for organising and leading the use of equipment during batch manufacture, organising and delegating tasks to junior team members and training team members
- Writing / adapting of relevant SOPs and documentation for specific unit operations and processes according to existing guidelines.
- Responsible for completing production records to principles of ALCOA+ prior to quality review. Escalating issues as they occur to the Head of GMP Operations, troubleshoot issues through technical expertise and report accordingly with all relevant information.
- Develop as a Subject Matter Expert (SME) in the organisation.
- Ensure timely completion of deviations, investigations and change controls and be able to lead investigations, identify root causes and propose SMART CAPAs.
- Act as a dedicated equipment owner, including trouble-shooting issues, ensuring equipment is serviced as per supplier agreements and remains in a validated state through periodic validation review.
- Liaise with partners/suppliers to maintain supply agreement and regarding facility maintenance, upgrades, and training.
- Be responsible for presentation of GMP operations processes and procedures in audits and inspections by regulatory authorities and customers.
- Any other duties commensurate with the role and the above responsibilities.
What we expect:
- A degree in life sciences / natural sciences.
- Sound knowledge of biotechnological processes & GMP manufacturing.
- A good understanding of the required industry standards for GMP manufacturing of investigational medicinal products.
- Experience of single use manufacturing and pilot scale or large-scale bioprocessing equipment.
What we will offer:
- 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