Scientist – Genomic Medicine Purification
| Company | Sanofi |
|---|---|
| Location | Waltham, MA, USA |
| Salary | $100500 – $145166.66 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Mid Level, Senior |
Requirements
- Earned PhD (preferred) in Biotechnology, Biochemistry, Chemical Engineering or related discipline OR Master’s degree with 4+ years of relevant experience OR Bachelor’s degree with 6+ years of relevant experience
- Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
- Significant experience, knowledge and understanding of purification technologies and operations (required) such as: Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.; Protein purification chromatography; Virus clearance and inactivation
- Expertise in technical report writing is necessary
Responsibilities
- Lead and conduct viral/non-viral vector purification process development and process analytics
- Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
- Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
- Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
- Perform troubleshooting experiments and communicate findings with appropriate working groups
- Maintain industry knowledge and keep abreast of new and relevant technologies
- Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
- Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
- Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
- Mentor and support junior staff and build a culture of support and collaboration
Preferred Qualifications
- Familiarity with advanced purification technologies and process analytical technologies is helpful
- Familiarity with analytical method transfer, analytical method bridging across organizations is preferred
- Experience with process technology transfers and performing gap analyses and risk assessments is ideal
- Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development is also preferred
- Experience in writing CMC components of regulatory dossiers
- Knowledge of product comparability, target product profile and quality risk assessment activities
- Viral clearance study design and execution
- Late-stage purification experience such as design space mapping and process robustness studies
- Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
- Ability to work under minimal supervision and function within a collaborative, team-oriented environment
- Excellent organization and communication skills
- Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
- Experience with biophysical characterization
- Experience in continuous manufacturing and process analytical technology
- Experience in mentoring junior staff
- Ability to build and nurture cross-functional relationships
- Ability to communicate and represent group in diverse, multi-functional meetings