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Position Objective: The Biologist will provide support services to satisfy the overall operational objectives of the National Institute of Allergy and Infectious Diseases within the National Institutes of Health.

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
• Assists with performing basic laboratory experiments and procedures
• Design library screening studies to enable evolution of lipid libraries on lipid nanoparticle formation, processing and in-process stability
• Optimize filtrations methods to support buffer formulation and concentration of mRNA-lipid nanoparticles, including sterile filtration and tangentially flow filtration (TFF)
• Evaluate 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
• Development high-throughput techniques for processing mRNA-LNPs, including parallel processing of library screen studies.
• Use microfluidic lipid nanoparticle technologies, e.g. Precision Nanosystems' Ignite, Blaze, or GMP unit.
• Use Impingement Jet mixing systems for lipid nanoparticle formation, e.g. Knauer integrated mixing systems
• Use of micro tangential flow filtration systems, e.g. Formulatrix uPulse systems.
• Support the Purification group of the Vaccine Production Program VPP Labs of the Vaccine Research Center 1
• Develop downstream purification processes, with minimal supervision for recombinant proteins, virus vaccines, and virus-like particles VLP that may be used as clinical vaccine candidates 2
• Independently design and execute experiments to optimize filtration TFF and NFF steps within purification processes for all clinical trial vaccine candidates 3
• Serve as a functional facilitator in chromatography development studies in vaccine and therapeutic mAb projects
• Purify research-phase recombinant proteins, virus vaccines andor virus-like particles in support of other groups at the VRC
• Facilitate the continuous centrifugation harvest clarification technology initiative in the VPP, including serve as subject matter expert in Unifuge system operation and maintenance; train VPP personnel in operation, maintenance, and equipment safety; author protocols and training guides for continuous centrifugation technology; perform role as tech transfer liaison to manufacturing facility, including consultation for design and operation of scale-up equipment
• Support technology transfer of processes to VRC Pilot Plant for manufacture of clinical product
• Write and review technical protocols and reports
• Analyze and compile data, present at various group department meetings and clean Equipment
• Meet with lab members to present updates
• Work 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
• Work products and documents related to working with the team to design, develop and optimize purification process for all clinical trial vaccine candidates
• Work products and documents related to writing and reviewing technical protocols and reports
• Work products related to production of mRNA and mRNA-LNP candidates. Including development work to support clinical production of mRNA-LNP clinical candidates
• Work products related to screening libraries of cationic lipids to develop novel lipid nanoparticle formulations for clinical trial evaluations

Basic Qualifications:

• Master’s degree in a science related field or equivalent.
• 1+ years of experience with mRNA technologies, including in vitro transcription and/or mRNA-lipid nanoparticle production
• 8+ years of exp. In recombinant protein purification development for GMP clinical-phase products

Preferred Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

This position is contingent upon contract award.