Principal Scientist, Analytical Development

The Role:

This position will be primarily responsible for establishing and managing analytical platform strategies to support the development of mRNA – lipid nanoparticles (LNP) as vaccines and therapeutics for clinical development program portfolio. The position will be responsible for strategic oversight and leadership focused on a full scope of analytical activities, including establishment of analytical control strategy, method development, qualifications and transfers, authoring and reviewing analytical sections for regulatory submissions, supporting CMOs/CROs and Moderna QC, and collaborating with Moderna Partner Analytical and Process Development teams, as well as Technical Development teams, Manufacturing and Quality. This position will be required to be a member of and work closely with Moderna’s Technical Development and CMC teams to ensure establishment and implementation of appropriate analytical approaches to support mRNA-LNP process and product development for clinical development programs. This position will lead a team of Scientists and Research Associates in a matrix environment. The position will report to the Senior Director, Analytical Development.

Here's What You’ll Do:

• Defines analytical strategy that is scientifically sound, appropriate and incorporates industry best practices and health authority expectations to support the development of mRNA-LNP as vaccines and therapeutics.

• Work closely with the mRNA development team to identify CQAs, analytical methods and develop robust specifications.

• Defines qualification/validation strategy and writes/reviews associated documents to ensure global compliance for analytical methods including HPLC, LC-MS, Capillary Electrophoresis, ELISA, Bioassay, Spectrophotometric and compendial methods.

• Leads and oversees Research Associates and Scientists in a matrix environment, and works with QC and CROs to enable and execute analytical testing, method development, transfer and qualification.

• Conducts periodic review of method performance and work with team to design and execute remediation experiments and implement changes to existing methods as applicable.

• Works collaboratively across organization for method readiness, transfer, performance and troubleshooting to support preclinical and ealy clinical development.

• Champions high throughput analytical testing approaches via the use of automation and robotics.

• In collaboration with others works on establishing phase appropriate platform approaches and analytical control strategies for different mRNA-LNP modalities/therapeutic areas.

Here’s What You’ll Bring to the Table:

• PhD in biological sciences, chemistry or related scientific disciplines with a minimum 5 years of industry experience in small and/or large molecules drug development.

• Demonstrated experience with development, validation, transfer and lifecycle of analytical methods used in biologics process development and/or manufacturing environment.

• Experience in analytical techniques such as UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, DSC.

• Prior management and mentorship experience and leading crossfunctional teams is a must.

• Good understanding of regulatory requirements: ICH, USP/EP/JP etc.

• Ability to work independently and manage projects in a timely manner.

• Ability to effectively document and communicate results.

• Strong interpersonal skills with an eagerness to support colleagues in cross functional teams.

• (Preferred) Experience in nucleic acid drug development (DNA, RNA, oligonucleotides).

• (Preferred) Experience working with both early and late phase drug development programs.

(Preferred) Experience working in matrix project teams with members from R&D, partners, CMOs and CROs.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
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