Principal Scientist, Analytical Development

Flagship Pioneering•Cambridge, MA

22h•$163,000 - $214,500•Onsite

About The Position

Mirai Bio, Inc is a Flagship backed, privately held biotechnology company on a mission to transform the current approach to information molecule therapeutics to unlock their full therapeutic potential. In recent years, we have begun to experience the power of information molecules in treating historically undruggable diseases and in designing therapies with unprecedented turnaround times. Mirai’s platform integrates nanoparticle development with world-class informatics technologies and a novel pipeline of experimentation and discovery to drive a new generation of highly effective, therapeutically relevant information molecule therapies. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Mirai was founded by Flagship Pioneering. Flagship Pioneering conceives, creates, resources, and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000, the firm has applied a unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $30 billion in aggregate value. The current Flagship ecosystem comprises 37 transformative companies, including: Moderna Therapeutics (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Indigo Agriculture, and Sana Biotechnology (NASDAQ: SANA). Position Summary: We are seeking a highly experienced and innovative Principal Scientist to lead analytical development activities focused on novel lipid nanoparticles (LNPs) and nucleic acid cargos (RNA/DNA) for therapeutics and vaccines. The successful candidate will play a critical role in method development, characterization, and control strategies for novel LNP compositions at different stages of development from platform research to IND+. The role requires deep expertise in analytical chemistry and physicochemical / biophysical analyses for nanoparticle and nucleic acid characterization.

Requirements

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related discipline with 8+ years of relevant industry experience; or M.S. with 10+ years.
Demonstrated expertise with analytical methods for lipid nanoparticle characterization, including biochemical / biophysical methods.
Experience with characterization of nucleic acid-based therapeutics (mRNA, siRNA, DNA).
Experience with characterization of proteins, mAbs, antibody fragments, and peptides
Hands-on experience with techniques including HPLC, DLS, NTA, CE, LC-MS/MS, UV-Vis spectroscopy, and single-particle characterization methods.
Excellent problem-solving, communication, and leadership skills.
Prior experience in a supervisory role

Nice To Haves

Experience working with external labs and/or CDMOs in a matrixed development environment.
Prior involvement in early stage development and IND filings, preferably for genetic medicines.
Familiarity with stability studies, forced degradation, and comparability assessments.
Familiarity with molecular biology and bioconjugation techniques
Awareness of ICH guidelines, GMP, and regulatory expectations for analytical method validation and CMC submissions.

Responsibilities

Lead analytical method development and testing for characterization of LNP-based drug products and nucleic acid drug substances (incl. RNA, DNA).
Oversee analytical team to provide broad testing support across R&D functions using platform methods including lipid and nucleic acid composition, integrity, purity, particle size, encapsulation, and more.
On-site presence and active hands-on involvement in experimental work is expected
Design and execute complex experiments for in-depth characterization using DLS, HPLC, LC-MS, SEC, FFF/SEC-MALS, CE, UV-Vis, NMR, Cryo-EM and other advanced techniques for nanoparticle characterization.
Collaborate with Formulation, Process Development, and Translational teams to support batch testing, stability characterization, optimization, and troubleshooting.
Contribute to establishing acceptable ranges for critical quality attributes (CQAs) and parameters (CPPs).
Manage/establish methods at external labs / CROs to complement internal capability.
Ensure lab instruments are in working condition, manage instrument vendors, and organize demonstrations of new equipment.
Prepare and review documentation including certificates of analysis, method protocols, laboratory notebooks, and reports.
Stay current with emerging analytical technologies and industry trends in LNP-based delivery systems, including targeted LNPs.
Supervise and mentor junior scientists and foster a culture of scientific and operational excellence.