Senior/Principal Research Associate, LNP Discovery/PD

Fapon • Boston, MA

43d

About The Position

We are seeking a scientific contributor to lead and execute novel LNP formulation process development activity for the delivery of circular RNA therapeutic at scale. This role will spearhead LNP process development/scale up activity and would be responsible for designing and executing DOE-based formulation process optimization. They would engineer and functionalize LNPs, develop analytics for formulation quality control, and develop processes to improve formulation at scale. The candidate would have the opportunity to work in a collaboration-oriented role in which they would coordinate with other teams, plan and run animal studies with a cross-functional group of scientists, and support the growth and career development of junior scientists. The ideal candidate is a chemical engineer/pharmaceutical major with strong LNP formulation, optimization, and process development experience, who is excited by the idea of being a core participant in building an early startup and guiding the scientific vision of the company. They would be engaged in science and driven by our mission to create therapies that help people in ways that are currently impossible.

Requirements

• BS/MS in chemical engineering, chemistry, pharmaceutical sciences, or related field, preferably with industry experience of 2-5 years for MS or 5-8 years for BS candidates.
• Strong track record of productivity in nanoparticle research with an understanding of key challenges in nanoparticle/formulation scale-up and translation
• Prior experience in developing lyophilization protocols for nanoparticle formulation, and stability testing is a plus
• Technical proficiency with LNP formulation of RNA and analytical assays for particle characterization
• Technical proficiency in developing cell and molecular biology assays to support drug product development
• A minimum of 3-4 years of experience working with lipid nanoparticles for RNA delivery in any capacity

Nice To Haves

• Demonstrated capability in LNP formulation for nucleic acid delivery is must
• LNP process development and scale-up experience is desired
• Experience with tissue-specific targeted delivery of LNP-nucleic acid formulation is a plus
• Demonstrated ability to present complex technical topics to a wide range of audiences with varying technical depth
• Demonstrated proficiency in record keeping and documentations to support SOP generation, technology transfer and preferably regulatory filings

Responsibilities

• Establish, execute and document protocols for preparation and characterization of targeted LNP formulations with nucleic acid cargo for in vitro and in vivo studies
• Design and execute DOE-driven studies for LNP composition, mixing parameters and process optimization to improve formulation quality, stability, delivery efficiency and functional activity
• Develop cell and molecular biology assays to assess the delivery efficiency of RNA cargo in mammalian primary cells to facilitate development of therapeutics drugs pipelines
• Assist in the buildout of formulation and analytical capabilities with focus on delivery with nanoparticle technology, lyophilization and process development for scale up/production
• Contribute to patent applications related to the delivery technology
• Support technology transfer to CDMOs and Industry Partners
• Foster collaborative relationships across the team and company and engage in a positive and exciting work environment
• Contribute to hiring, training, and collaborating with scientists (as needed) to formulate, characterize, develop, and support assessment of efficacy
• Plan and coordinate animal studies with in vivo team
• Author technical documents, including SOPs for formulation processes and analytical methods, maintain diligent records and demonstrate proficiency in scientific communication
• Support high-quality documentations to support regulatory filings

Benefits

• Financial security through competitive compensation, incentives, and retirement plan
• Health care and well-being programs including competitive medical, dental, vision & medical benefits
• Generous paid time off including vacation, sick time, holidays, and winter shutdown
• 401(k) retirement savings with a generous company match
• Commuter benefits
• Other comprehensive voluntary benefits include but are not limited to pet insurance, life insurance, employee assistance program (EAP), discount programs, and many more

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1,001-5,000 employees