Scientist/Sr. Scientist, Lnp Process Development

Job Description:

Arranta Bio is seeking a candidate with strong LNP and formulation process sciences experience. The Candidate The candidate will be working on developing, optimizing, and scaling up lipid nanoparticles formulations. The candidate will help with clients` tech transfer operations as well as support new Process Development proposals and initiatives for clients.

Responsibilities:

• Develop and optimize process parameters on particle formations such as: fractional flow rate, total flow rate and establish correlations.
• Develop and optimize tangential flow filtration process parameters, such as: loading capacity, flux rate, shear rate and transmembrane pressure (TMP).
• Compare and test new emerging technologies for the particle generation, such as microfluidics, tee mixing and jet mixing.
• Investigate and design the experiments using statistical analysis tools.
• Conduct comparability studies for excipients and buffers.
• Collaborate cross-functionally with other departments including process engineering, tech transfer, drug substance, and analytical development.
• Write, review, and approve scientific documentations (Batch records, SOPs, protocols, reports, etc.).
• Follow good laboratory practices and have GMP experience with Working knowledge of pharmaceutical/biotech processes.
• Follow Good documentation processes for both internal and client's work.
• Design & execute tech transfer that are complex and technically challenging.

Education & Experience

• D. in pharmaceutical sciences or Engineering discipline with 3-5 years, or M.S. with 4-6 years experience in pharmaceutical industry with hands-on formulation/Process Development, and technology transfer to support LNP and other drug product manufacture.
• Heads on experience with formulation screening, Process Development, and process optimization.
• Heads on experience with technology transfer and/or scale up processing activities in Process Development.
• Experience with pharmaceutical unit operations including, but not limited to, LNP manufacturing via T-mixing, microfluidic mixing and/or impingement jet mixing, light scattering techniques, assay execution and development, tangential flow filtration.
• Experience with characterization instruments including, but not limited to dynamic light scattering, fragment analyzer/CE, bioanalyzer/gel electrophoresis, UV-spectroscopy, osmolality. HPLC and/or mass spectrometry are a plus.
• Experience with mixing studies, shear rate calculations, and scale-up
• Understanding of safe lab practices and BSL requirements.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
• The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle.

Work Environment

This will be a lab and office-based position.