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
JR2092
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 1.400 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!
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
- Use QbD principles to design and execute experiments related to development, optimization, and scale down/ scale-up of all mammalian cell culture unit operations utilizing shake flasks, high-throughput AMBR systems, and bench scale to 200L pilot scale bioreactors.
- 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.
- 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
-
Specific experience with the following:
- Creating cell banks
- Developing depth filtration and disc stack harvest unit operations
- Proficiency in programming and operating the AMBR 250 high-throughput bioreactor system
- Use of statistical tools such as JMP or MODDE
- Familiarity with ICH guidelines
- Process characterization using QbD principles
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
