What are the responsibilities and job description for the Scientist, Upstream Process Development position at Rentschler Biopharma SE?
locations
Milford, MA, United States
time type
Vollzeit
posted on
Heute ausgeschrieben
job requisition id
JR2170
Medizin vorantreiben, um Leben zu schützen. Gemeinsam.
Dank vieler Jahrzehnte Erfahrung und unserer Leidenschaft für das, was wir tun, leisten wir einen essenziellen Beitrag zur weltweiten Verfügbarkeit von Biopharmazeutika, auch und gerade für Patienten mit seltenen und schweren Erkrankungen.
Rentschler Biopharma SE ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) und ausschließlich auf Kundenprojekte fokussiert. Wir bieten maßgeschneiderte Full-Service-Lösungen für die Bioprozessentwicklung und die Herstellung komplexer Biopharmazeutika. Als deutsches Familienunternehmen mit internationalem Footprint und globaler Reichweite verbinden wir Experten, Expertise und langjährige Erfahrung, um zusammen mit unseren Kunden beste Lösungen zu entwickeln.
Rentschler Biopharma beschäftigt rund 1.400 Mitarbeiter und hat den Hauptsitz in Laupheim, Deutschland, sowie einen Standort in Milford, MA, USA. Im Jahr 2024 haben wir uns dem Global Compact der Vereinten Nationen angeschlossen und unterstreichen damit unser Engagement für Nachhaltigkeit.
Als unabhängiges Familienunternehmen leben wir nach dem Motto: Many hands, many minds – ONE TEAM! Ein offenes, respektvolles Miteinander prägt unsere Arbeitswelt, in der Qualitätsbewusstsein, Sorgfalt und Verantwortung an erster Stelle stehen. Denn bei aller Vielfalt unserer Talente im Rentschler Team verfolgen wir gemeinsam einen Zweck: Medizin voranzutreiben, um Leben zu schützen.
Duties and Responsibilities
- Development of scale-able and robust upstream processes including process characterization, and/or technology transfer to clinical and commercial GMP manufacturing while meeting the project deliverables
- Design and execute experiments related to development, optimization, and scale down/ scale-up of all mammalian cell culture unit operations
- Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
- Ability to work in a team environment and drive the success of the team
- Apply advanced statistical techniques to design experiments related to process development and characterization
- Author high-quality documents, including technical reports, SOPs, and experimental protocols
- Serve as a Process Development representative and participate in cross functional meetings
- Contribute to scale up activities and draft technical transfer related documents (e.g. process description, process flow diagram)
- Review batch records and provide comments
- Support MFG floor activities and process deviations including effective CAPAs
- Provide technical support (e.g. process/operational gap identification and troubleshooting) to MSAT and the manufacturing group
- Compile and present data at client project teams and author reports
- Contribute to the overall operations of process sciences lab and infrastructure improvements
- Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
- Train and/or lead Associate Scientists
Qualifications
- A university degree and 5 years of related experience
- A Master’s degree and 3 years
- A PhD and 1 years(s) of experience
- Solid theoretical knowledge and hands-on experience cell culture process development, including aseptic technique and bioreactor operation
- Desirable experiences: Cell Banking, Harvest Unit Operations, AMBR operation, MODDE statistical tools, ICH guidelines
- The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
- Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)
- Demonstrates ability to work both independently and as a member of local / global teams
- Excellent customer service skills and ability to meet client project deadlines
- Flexibility of hours to support laboratory and MFG floor activities. Weekend and holiday hours are compensated per HR company policies
- Flexibility to switch between projects
Working Conditions
- Laboratory environment working with chemical reagents and genetically modified cells
- Personal Protective Equipment must be worn as required
- Normal office working conditions: computer, phone, files, fax, copier
- Will interact with other people
- Pace may be fast and job completion demands may be high
Physical Requirements
- PPE as required
- Frequent lifting up to 10 lbs
- Frequent standing/walking to work in lab environment for extended periods
- Frequent sitting for extended periods to use computer
Brauchen Sie Hilfe?
Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team:
welcome@rentschler-biopharma.com