Senior Scientist, DSP Process Engineer - Tech Transfer and Production Support
Role details
Job location
Tech stack
Job description
As Senior Scientist, DSP Process Engineer within our BioProcess Engineering (BPE) team, you'll lead technical transfer activities and provide critical production support for biologics manufacturing across our global network. Ready to get started?
The BioProcess Engineering (BPE) team, part of the Mammalian Platform unit of the Global CMC Development organization, is responsible for the execution of pilot-scale batch manufacturing and technical transfers for all levels of clinical development. For early-phase clinical material production, BPE acts as receiving site coordinator on behalf of our manufacturing facilities. For late-stage clinical, early-stage commercial, and external clinical material production, BPE acts as the sending site coordinator and works closely with process owners, sourcing partners, and the Manufacturing & Supply organization., * Lead technical transfer activities including facility-fit assessment and operational readiness assessment and provide technical support as SME (Subject Matter Expert) for processes (mainly DownStream Process)
- Support GMP manufacturing operations and act as Drug Substance lead for programs from Cycle 1 to Cycle 3 when necessary
- Partner with all relevant functions from R&D and Manufacturing & Supply to perform facility fit assessment, GMP operational readiness assessment, and authorize transfer documents
- Act as a data steward by gathering and compiling process data for projects with support from Development, GMP manufacturing, and Analytics teams for development runs, scale-up batches, and GMP batches
- Create data visualizations for reviews, assessments, and process anomaly root cause analysis
- Lead evaluation and implementation of new process platforms and manufacturing technologies
- Write and revise protocols, procedures, reports and other process-related documentation to support process scale-up, transfer, and implementation to cGMP manufacturing operations
Requirements
- Engineering Degree in Chemical Engineering, Biochemistry, Biotechnology, or related field with industrial experience in manufacturing or process development of biologics
- Experience in leading matrix teams
- Excellent oral and written communication skills to build relationships both inside and outside the company
- Experience working on multiple complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities
- Fluent in English, French speaking in writing, reading and presenting
Skills that you could improve in this new position (to develop):
- Experience in manufacturing or process development of biologics, preferably produced in recombinant protein purification systems, with knowledge on scale-up, process transfer, and cGMP manufacturing operation
- Working knowledge in recombinant protein GMP quality standards and regulatory requirements
- Experience in defining process control strategy and process validation and performing risk assessment following the QbD principle
- Experience in Data Analysis using existing tools and willingness to develop/evaluate new ones in the context of the global Digitalization strategy
Skills that you could offer in addition (nice to have):
- Ability to gown and work in manufacturing areas
- Ability to work flexible hours
- End-to-end biologics process knowledge, including cell culture and formulation knowledge, Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.