Scientist/ Senior Engineer, LNP Process Development

Company Summary:

Laronde is pioneering a platform that offers a completely novel way of modulating human biology via Endless RNA™ (eRNA). eRNA is a uniquely engineered RNA that can be programmed to express diverse proteins inside the body. Laronde is rapidly scaling to support the development of multiple programs across many disease areas. ​

Laronde was founded in 2017 by Flagship Labs, the innovation foundry of Flagship Pioneering. Laronde has a highly collaborative, dedicated culture, driven to achieve our vision of “making eRNA an essential class of medicines to everyone, everywhere”. To learn more, please visit the company’s website at https://www.laronde.bio.

Position Summary:

Laronde is seeking a creative and motivated Scientist/Senior Engineer to develop scalable and efficient processes for Lipid Nanoparticles (LNP) manufacture. In this role, you will work cross functionally within Technical Development (Analytical Development, Pilot Plant, GMP Manufacturing and Quality) as well across the broader research organization to ensure innovative processes are applied to enable Laronde’s platform technology and deliver novel eRNA based therapeutics to the clinic. We are searching for driven, enthusiastic, team oriented and self-motivated individuals who are comfortable multitasking and working independently on various aspects of the platform.

Key Responsibilities:

• Develop robust, efficient & scalable processes for Lipid Nanoparticles appropriate for GMP production of early clinical development.
• Define development strategies, and design the supporting experimental plans to ensure data driven decision making
• Generate and analyze data sets to support establishment of process design space
• Develop, optimize and define processes for LNP drug products.
• Collaborate with manufacturing, MS&T, and quality groups to ensure successful, safe and compliant process transfer and execution.
• Collaborate with Analytical development to characterize materials and processes, and identify potential cQAs and CPPs
• Maintain appropriate documentation for scientific data, experimental protocols, development reports and technology transfer documentation.

Qualifications:

• Scientific or Engineering degree with >6 years direct industry experience in process development of biologics and/or novel delivery systems.
• Expertise in nanoparticle formulation process development and optimization.
• Experience in process optimization and scale-up of TFF operations preferably using flat sheet TFF technology.
• Knowledge of process scale-up, scale-down model development, and process characterization and modeling is essential.
• On floor manufacturing in a GMP facility, strong preferred
• Expertise in statistical design of experiments (DoE) and multivariate analysis.
• Demonstrate the following skills

·        Action-oriented, team player, and highly motivated, with strong work ethic.

·        Excellent verbal and written communication.

·        Ability to excel in a fast-paced, dynamic, innovative environment.

 

Laronde is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

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