Primary Responsibilities:• Work on lipid nanoparticle (“LNP”) manufacturing • Focus on scale-up and optimization of lipid nanoparticles, supporting delivery of base editors • Contribute to the development and scaling of a manufacturing process in order to bring in-vivo base editing to patients • Work on process manufacturing, optimization and nanoparticle formation; large biomolecule production; manage aseptic unit operations for sterile drug product manufacture; and process and analyze frozen and lyophilized formulations for clinical-stage drug product • Design and execute experiments to optimize nanoparticle formulation and manufacturing processes deployed, including in the area of tangential-flow filtration and mixing • Execute laboratory-based experiments, supporting a robust reproducible process, underlying key manufacture of clinical trial materials used at Beam • Design and execute laboratory experiments used to evaluate and optimize stability of drug product • Support development of automated processes for LNP manufacturing across mixing geometries, scales, components and payloads • Engage in technology transfer exercises, both within the company and externally, as a subject-matter expert in the area of LNP drug product manufacturing • Contribute to related process development initiatives involving change controls, process deviations, and write material focused on promoting quality engineering excellence • Supports data aggregation and analysis of corporate LNP manufacturing having internal and external applications in order to effectively define process characterization, optimization, and control activities, used and deployed • Contribute to generating high-quality documentation for scientific-focused Standard Operating Procedures, applied at Beam Therapeutics • Contribute to generating high-quality scientific content in support of regulatory filings, made and advanced by Beam Qualifications (one way to qualify):• Bachelor’s degree or foreign equivalent in bioengineering, biomedical engineering, chemistry, chemical engineering, pharmaceutical sciences, or related field; and • Also requires possession of five years of progressive, post-baccalaureate experience in all of the following areas: • Applying Current Good Manufacturing Practices regarding large biomolecule production and aseptic unit operations for sterile drug product manufacture; and • Engaging in LNP process development or manufacturing; and • Manufacturing frozen or lyophilized formulations in support of clinical-stage drug product.
