Biologist

Duties And Responsibilities

• Serve as subject matter expert (SME) on mRNA-LNP process development and production.
• Keep up to date on leading industry practices and investigate new techniques for implemented LNP production.
• Produce mRNA-LNP materials needed for analytical development and formulation stability studies.
• Affords assistance with performing basic laboratory experiments and procedures.
• Designs library screening studies to enable evolution of lipid libraries on lipid nanoparticle formation, processing, and in-process stability.
• Optimizes filtrations methods to support buffer formulation and concentration of mRNA-lipid nanoparticles, including sterile filtration and tangentially flow filtration (TFF).
• Evaluates process efficiency by measuring encapsulation rates of mRNA and process-related impacts on yield and product quality.
• Maintains inventory of lipid nanoparticle components, including cationic lipids, helper lipids, cholesterols, and pegylated lipids.
• Explores new filtration membrane technologies including membrane type and system configurations to maximize processes yields and quality of lipid nanoparticles.
• Develops high-throughput techniques for processing mRNA-LNPs, including parallel processing of library screen studies.
• Uses microfluidic lipid nanoparticle technologies, e.g., Precision Nanosystems' Ignite, Blaze, or GMP unit.
• Uses Impingement Jet mixing systems for lipid nanoparticle formation, e.g., Knauer integrated mixing systems.
• Uses micro tangential flow filtration systems, e.g., Formulatrix uPulse systems.
• Supports the Purification group of the Vaccine Production Program VPP Labs of the Vaccine Research Center 1.
• Independently designs and executes experiments to optimize filtration TFF and NFF steps within purification processes for all clinical trial vaccine candidates.
• Serves as a functional facilitator in chromatography development studies in vaccine and therapeutic mAb projects.
• Purifies research-phase recombinant proteins, virus vaccines, and/or virus-like particles in support of other groups at the VRC.
• Facilitates the continuous centrifugation harvest clarification technology initiative in the VPP, including serves as subject matter expert in Unifuge system operation and maintenance; trains VPP personnel in operation, maintenance, and equipment safety; authors protocols and training guides for continuous centrifugation technology; performs role as tech transfer liaison to manufacturing facility, including consultation for design and operation of scale-up equipment.
• Writes and reviews technical protocols and reports.
• Analyzes and compiles data, presents at various group department meetings, and cleans Equipment.
• Meets with lab members to present updates.
• Works products and documents related to developing downstream processes for recombinant proteins, virus vaccines, and virus-like particles (VLP) that could be used as clinical vaccine candidates.
• Works products and documents related to working with the team to design, develop, and optimize purification process for all clinical trial vaccine candidates.
• Works products and documents related to writing and reviewing technical protocols and reports.
• Works products related to production of mRNA and mRNA-LNP candidates, including development work to support clinical production of mRNA-LNP clinical candidates.
• Works products related to screening libraries of cationic lipids to develop novel lipid nanoparticle formulations for clinical trial evaluations.

Qualifications

PhD in Biochemistry, Molecular Biology, Microbiology, Immunology, or a related field with 5+ years of relevant experience, or MS with 7+ years of relevant experience.

Experience with mRNA-LNP process development and production.

Experience with lipid nanoparticle formulation and stability studies.

Experience with high-throughput techniques for processing mRNA-LNPs.

Experience with microfluidic lipid nanoparticle technologies.

Experience with Impingement Jet mixing systems for lipid nanoparticle formation.

Experience with micro tangential flow filtration systems.

Experience with continuous centrifugation harvest clarification technology.

Experience with Unifuge system operation and maintenance.

Experience with writing and reviewing technical protocols and reports.

Experience with analyzing and compiling data, presenting at various group department meetings, and cleaning Equipment.

Experience with meeting with lab members to present updates.

Experience with working products and documents related to developing downstream processes for recombinant proteins, virus vaccines, and virus-like particles (VLP) that could be used as clinical vaccine candidates.

Experience with working products and documents related to working with the team to design, develop, and optimize purification process for all clinical trial vaccine candidates.

Experience with working products and documents related to writing and reviewing technical protocols and reports.

Experience with working products related to production of mRNA and mRNA-LNP candidates, including development work to support clinical production of mRNA-LNP clinical candidates.

Experience with working products related to screening libraries of cationic lipids to develop novel lipid nanoparticle formulations for clinical trial evaluations.