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 single?use 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).