Principal Research Associate, Analytical Development

The Role: In this role, you will primarily focus on managing the analytical control strategy to support large-scale process development and optimization for plasmid DNA, cell-free DNA and enzymes. Responsibilities include driving analytical control strategies and associated deliverables, such as test method development, optimization, pre-qualification, qualification, and validation; specification setting; and the timely initiation of IPC, release, characterization testing and stability studies. The role will also support investigations related to release and stability data. You are expected to work in a highly collaborative, cross-functional team environment, and interface with different departments as well as technical and operational teams. The individual must thrive in a fast-paced environment with high expectations. Integrity, ability to pay attention to detail and troubleshoot, curiosity, collaborative spirit, respect for people, exemplary work ethic and setting the bar high are key values to thrive in this team. This role is located at the Moderna Technology Center in Norwood, MA. Here’s What You’ll Do: Partner closely with the Analytical Program Lead for DNA and Enzymes to drive analytical control strategies that support large-scale process development and optimization for plasmid DNA, cell-free DNA, and enzymes. Develop and maintain tracking systems to monitor analytical deliverables, including test method development, optimization, pre-qualification, qualification, and validation; specification setting; and timely initiation of IPC, release, characterization testing, and stability studies. Collaborate with cross-functional stakeholders to ensure timely procurement and availability of analytical testing materials Support investigations of out-of-specification (OOS) and out-of-trend (OOT) results in collaboration with Analytical Development SMEs, Analytical Technical Operations, and Quality, as needed. Generate high-quality technical documentation to support regulatory submissions and internal communications. Serve as a subject matter expert in analytical control strategies for DNA and enzymes, supporting cross-functional teams including Analytical Development, Process Development, Manufacturing, Quality, Supply Chain, and CMC Regulatory. Here’s What You’ll Need (Basic Qualifications) MS with 5 years or BS with 8 years of biotech or pharmaceutical industry experience in analytical development. Strong background in chromatographic separation, biophysical characterization, and spectrophotometric techniques, equipment platforms (e.g. Thermo, Waters, Agilent), and data processing software (e.g. Chromeleon, ChemStation, Empower) (Preferred) Understanding of critical quality attributes and analytical test methods for biologics including plasmid DNA, proteins, enzymes, mRNA and lipid nanoparticles (Preferred) Experience with method development and qualification (Preferred) Experience with program or project management Knowledge of industry standards and current FDA and ICH guidelines Excellent written and oral communication skills; strong organizational skills and attention to detail (Preferred) Familiarity with electronic notebooks, LES, LIMS and Veeva quality management system Ability to work independently and as part of a team, self-motivation, adaptable, and a positive attitude. Ability to prioritize work and experience in managing multiple projects in a fast-paced environment. This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US be ... (truncated, view full listing at source)