Senior Scientist – Downstream Process Development
The Sr. Scientist, Downstream Process Development, provides development and execution of experiments designed to optimize recombinant adeno-associated virus (rAAV) downstream processing and purification for gene therapy applications. This role requires working knowledge of process scale up, preferably in chromatography, UF/DF and depth filtration.
Responsibilities and accountabilities
- Develop robust, efficient, scalable strategies for improving downstream process performance in collaboration with fellow scientists, collaborators and senior management
- Lead, execute and support process improvement activities and projects using engineering principles, statistical analysis and equipment knowledge
- Conduct experiments and analyses as part of a variety of research and development activities, e.g., small-scale studies, scale-up studies, technology transfer and process development
- Actively participate as a member of multi-functional project teams, executing projects from concept to implementation
- Evaluate and summarize the experimental results, develop and test hypotheses to improve understanding of downstream purification strategies, yield, purity and recovery
- Support technology transfer internally and externally, manufacturing and quality by design
- Prepare internally reviewed technical reports, CMC documents, manuscripts and internal and external oral presentations
About you
- MS or PhD degree in an engineering discipline (chemical/biochemical engineering, or equivalent)
- Recent PhD graduate or MS with minimum 4-6 years of experience in laboratory research required, preferably in recombinant protein/biomolecule purification development, technology transfer and/or bioprocess manufacturing
- Experience in laboratory research and a desire to continue in a laboratory-focused role
- Experience with filtration and chromatography
- Familiarity with GLP and cGMP
- Demonstrated ability to generate results and innovative solutions with minimum supervision
- Strong academic record
- Good understanding of protein chemistry, protein analytics and bioprocess technology is required
- Self-motivated, organized, capable of working independently, as well as in a collaborative/group environment to collaborate with manufacturing staff on experimental studies and GMP manufacturing
- Experience with recombinant adeno-associated viral vector manufacturing is a plus
- Experience with downstream process development specific to recombinant adeno-associated virus is a plus
- Strong oral and written communication skills
- Good judgment and innovation to achieve a solution within standard practices and procedures
- Strong analytical and computer skills are required
- Sound understanding of statistical experimental design and analysis, such as design of experiments, is a plus
- Knowledge of Microsoft Office suite (Word, Outlook, Excel) required; experience with JMP a plus
- Experience with multi-functional groups a plus
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