Solid Biosciences is seeking a Senior Process Engineer to support activities related to internal and external technology transfer, manufacturing floor support, floor trouble shooting and root cause analysis. In addition, this role will support our late phase downstream purification process development activities, process scale up, and process characterization. Solid is looking for downstream process development candidates with experiences in purification process development, process characterization, Engineering scale up/down and technology transfer. Some experience in leading junior members is preferred.
Key Duties & Responsibilities:
- Development of scale-able and robust downstream processes
- Design experiments related to development, optimization, scale-up of all steps in a viral vector purification process and viral clearance study, execute studies together with junior members
- Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
- Apply DOE and other advanced statistical techniques to design experiments related to process characterization
- Author high-quality documents, including technical reports, SOPs, and experimental protocols
- Serve as PD representative and participate in cross functional meetings
- Contribute to scale up activities and draft tech transfer related documents (e.g. process description, process flow diagram)
- Conduct facility fit exercise
- Review batch records and provide comments
- Support MFG floor activities
- Provide technical support (e.g. process/operational gap identification and troubleshooting) to MFG group
- Support Solid’s Quality Assurance teams to help evaluate deviations, CAPA and Change Controls (both internal and external)
Education, Experience & Skills:
- A university degree and 12+ years of related experience OR Master degree and 9+ years or PhD and 6+ years is required
- Solid theoretical knowledge and hands-on experience in protein purification and analytical characterization.
- Hands-on experience with purification unit operations including filtration, different mode chromatography, UF/DF, AKTA, UNICORN, centrifugation
- The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills.
- Flexibility to switch between projects
- Up to 30% of travel is required at times