Scientist / Engineer

About the Role

• Location: Waltham, MA
• Support the Formulation and Process Development group.
• Reports to the DP Group Lab Team Lead.

Key Responsibilities

• Lead formulation optimization and/or process understanding of mRNA-containing lipid nanoparticle (LNP) formulation and production processes.
• Work closely with the Research team in transferring and accelerating new LNP composition formulation into CMC development.
• Design and conduct small-scale multi-component LNP formulating experiments to understand the developability of new LNP formulations.
• Lead the compilation of Developability package for new LNP formulations.
• Develop initial formulation process for new LNP formulations.
• Design and arrange studies to assess the stability of new LNP formulations.
• Performing in-process drug product characterization.
• Perform complex and routine analytical methods to characterize new formulations and troubleshoot.
• Coordinate/Suggest/Introduce advanced LNP characterization analysis with the Analytical Sciences department.
• Support the Drug Product team to troubleshoot technical, formulation, and processing issues.
• Document development study set up, results, and conclusions within an electronic lab notebook.
• Tabulating and analyzing in-process and post-process characterization data.
• Summarize and present study progress, generated data, and analysis to scientific team members and group meetings.
• Support growth and expansion goals by setting up and installing new characterization and process equipment.

Requirements & Tech Stack

• Bachelor's in Engineering, Pharmaceutical Sciences, or Chemistry related science discipline, with 5 or more years of professional experience in formulation and/or process development.
• Master's in Engineering, Pharmaceutical Sciences, or Chemistry related science discipline, with 3 or more years of professional experience in formulation and/or process development. (Internships and co-ops experience will be considered)
• Ph.D. in Engineering, Pharmaceutical Sciences, or Chemistry related science discipline, with a minimum of 6 months of experience in formulation and/or process development. (Academic experience will be considered)

Qualifications

• Strong scientific understanding of formulation and process development in a pharmaceutical environment.
• Ability to independently design experiments, analyze complex datasets, and recommend development strategies.
• Strong organizational and communication skills with the ability to work and communicate cross-functionally.
• General understanding of common LNP production process and analytical characterization techniques is desirable, prior experience running these techniques is a plus.
• Desire to work in a fast-paced environment.
• Ability to be flexible and responsive to change, be a results-driven problem solver.