SUMMARY
This innovative biopharmaceutical company is looking for an R&D scientific leader with a strong background in Upstream Bioprocessing for cell & gene therapy to join their cross functional team as an individual contributor to facilitate IND, Phase I & II enabling activities advancing programs to BLA.
RESPONSIBILITIES:
- Independently design, develop, and execute experiments for bioprocess development, optimization, and characterization.
- Execute adherent and suspension small-scale bioreactor-based cell culture processes for manufacturing of gene therapy vectors across multiple programs.
- Coordinate with internal & external partners for deliverables and timelines related to testing, optimizing, & advancing new cell therapy programs from early development through clinical trials.
- Cell therapy upstream process development and analytics, including product characterization, process parameter optimization, and singleโuse bioreactors
- Serve as the SME all bioprocessing activities that support clinical development and IND/BLA filing.
- Provide technical oversight, guidance, troubleshooting, and provide new approaches or experimental strategies for problem solving to ensure that clinical materials are delivered on schedule.
- Write and evaluate CMC sections & technical reports needed for regulatory submissions.
QUALIFICATIONS:
- Master's or PhD in Chemical Engineering, Microbiology, Biochemistry, or related degree with 1 year min. of industry experience (PhD) or (MS +3-5 years) developing upstream processes.
- Prior hands-on experience with stirred tank bioreactors for adherent and suspension cell cultures
- Experience with iPSC, mesenchymal stem cell, T cell, or NK cell expansion using bioreactors.
- Track record of successfully executing Design of Engineering (DoE) approach.
- Prefer experience with multivariate data analysis, predictive analytics, and machine learning. Prefer multivariate or machine learning data analytics experience (JMP, python, R).
