Principal Scientist, Analytical Development

COMPANY DESCRIPTION

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.

Key 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.

Qualifications:

• 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

Preferred Skills:

• 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.

ABOUT FLAGSHIP PIONEERING

Flagship Pioneering invents and builds platform companies, each with the potential for multiple products that transform human health, sustainability and beyond. Since its launch in 2000, Flagship has originated more than 100 companies. Many of these companies have addressed humanity’s most urgent challenges: vaccinating billions of people against COVID-19, curing intractable diseases, improving human health, preempting illness, and feeding the world by improving the resiliency and sustainability of agriculture.

Flagship has been recognized twice on FORTUNE’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies and has been twice named to Fast Company’s annual list of the World’s Most Innovative Companies. Learn more about Flagship at www.flagshippioneering.com.

At Flagship, we accept impossible missions to enable bigger leaps. Our core values guide us through uncertainty and toward lasting impact.

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

We recognize that great candidates often bring unique strengths without fulfilling every qualification. If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background and interest in Flagship.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

The salary range for this role is $163,000 - $214,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Mirai Bio currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Mirai Bio's good faith estimate as of the date of publication and may be modified in the future.