Scientist / Engineer

Job title: Scientist / Engineer

• Location: Waltham, MA

About the job

The USA-mRNALNP Drug Product Team supports the Formulation and Process Development group in Waltham, MA, and reports to the DPGroup Lab Team Lead. We are seeking an individual with process development and/or formulation and good laboratory skills and scientific understanding of formulation development experience to contribute to bringing innovative new vaccines to the market.

Main Responsibilities:

• Lead the formulation optimization and/or process understanding of mRNA-containing lipid nanoparticle (LNP) formulation and production processes encompassing a wide range of different mRNAs and novel lipids.

• 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 to troubleshoot as needed.

• 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 other scientific team members and larger group meetings

• Supporting the growth and expansion goals by setting up and installing new characterization and process equipment into new laboratories

About you

Basic Qualifications

• 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

Key Skills, Abilities, and Competencies

• Strong scientific understanding of formulation and process development in pharmaceutical related 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

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information canbe found here.