- Support planning and execution of experiments and associated analysis and reporting
- Provide downstream process development support in a team-based environment for viral vector technical development studies performed both internally and externally
- Support technology transfer to partners at external contract manufacturing organization including compilation of documentation (protocols, test methods, reports)
- Participate in laboratory set up and equipment procurement, and establish internal process development practices with special emphasis on chromatographic separation methods
- Author relevant documentation (protocols, technical development, qualification reports)
- Organize, communicate, and present data to key stakeholders, senior management, and external partners
- Interface and work collaboratively with CDMO and testing lab partners
- Proactively enable cross-functional collaborations with internal stakeholders, external partners, and consultants
- Bachelor's or Master's degree in a relevant scientific area such as biotechnology, bioprocess, molecular biology, immunology, biochemistry, or virology (required), with 8+ years of experience for BS, 6+ years' for MS, or 3+ years' for PhD
- 2+ years of relevant experience in downstream viral vector concentration and purification techniques; lentiviral vector experience preferred
- Must have a strong understanding of viral vector production methods, cell culture, and other relevant methods of vector characterization; lentiviral vector experience preferred
- Experience using AKTA chromatography systems and associated Unicorn software
- Experience with anion exchange chromatography
- Ability to work in a highly adaptive environment and learn new skills for changing priorities.
- Flexible and creative, with ability to think outside the box
- Strong interpersonal, organizational, written, and verbal communication skills
- Must be a strong team player and willing to work collaboratively in a small team environment
- Flexibility with work schedule/on-site availability (i.e., occasional weekend work) as we are building the team
- Willingness to travel (up to 10-20%)
- Prior experience in downstream viral vector process development preferred, especially as related to lenti and/or retroviral vectors
- Experience with viral vector scale-down models (5-10L scale) preferred
- Experience with cross flow/tangential flow (TFF) concentration of viral vectors using hollow fiber modules is a plus
- Experience with Design of Experiment (DoE) and Failure Mode & Effects Analysis (FMEA) based approaches is preferred
- Experience with multi-color flow cytometry is a plus
- Experience with electronic lab notebooks and inventory system is preferred
- Proficiency in Office, Design of Experiments, JMP, Prism, and other productivity and data analysis tools is a plus
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