We are currently seeking qualified candidates for a Senior Upstream Process Development Scientist position with a leading global multinational life sciences company. This is a permanent position that will be based out of Massachusetts, United States.
PURPOSE
The Senior Process Development Scientist will work in the upstream team for process development or process validation projects (monoclonal antibodies or fusion-proteins). The Scientist will oversee production using mammalian cells and will support the implementation, coordination, development &, troubleshooting for the mammalian cell processes. The successful candidate will be responsible for the transfer & troubleshooting of mammalian production processes (media buffer preparation, cell culture & purification).
RESPONSIBILITIES
- Execute upstream activities on client projects according to budget and timelines given to the project team
- Design and execute fit-for-purpose cell culture experiments according to the stage of development
- Compile and analyze experimental data to generate process knowledge and decide on next steps
- Write development and validation reports and ensure their timely delivery
- Prepare and present project updates to global project team and to upper management
EDUCATION, SKILLS & EXPERIENCE
- Masters degree in biotechnology or engineering
- 5+ years in the biopharmaceutical industry
- Hands-on experience in process development and manufacturing of monoclonal antibodies. Knowledge of quality attributes of glycoproteins a must.
- Hands-on experience in process validation is a plus
- Quality mindset and good understanding of Good Manufacturing Practices
- Excellent presentation and communication skills
- Results-oriented with ability to work and deliver under pressure
- Excellent English (written, oral)