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 biochemistry and related chemistries, preferably in chromatography, centrifugation and filtration design principles.
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 improvements 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 or multifunctional 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) or recent PhD or MS graduate with minimum 4-6 years’ 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
- 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 manufacturing of recombinant adeno-associated viral vectors 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 multifunctional groups a plus
- Responsible for maintaining up-to-date knowledge of regulatory requirements and quality standards related to area of development
