Sr. Scientist, Bioanalytical and Molecular Assays

The Role:

Moderna's Bioanalytical and Molecular Assay team is looking for a Sr. Scientist with strong hands-on experience in the regulated bioanalytical LC-MS/MS area within GLP/GcLP regulations. The individual should have recent experiences in the processing and analysis of a wide range of molecules such as lipids, proteins, peptides, oligos, etc. The role will support method development and validation for the clinical development of candidates applying cutting-edge LC/MS techniques toward mechanistic and quantitative assessment of Moderna's mRNA-LNP therapeutics. The candidate must thrive in a scientifically stimulating, fast-paced environment with high expectations. Independent method development, validation, ability to troubleshoot, collaborate with cross-functional teams, respect for peers/colleagues, excellent work ethic, and setting the bar high are key values to thrive in our Team. 

Here's What You'll Do:

• Lead regulated bioanalytical projects from method development to validation and sample analysis in order to support various Moderna Clinical Programs under GLP/GcLP compliance. 

• Develop, qualify, and/or validate LC/MS methods for the quantitation of various types of biomolecules, particularly lipids, proteins (peptides), amino acids, and Oligos

• Evaluate and review raw data, assay validation reports, sample analysis reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Moderna standards and that data are of the required quality (regulatory and scientific).

• Support nonclinical studies to evaluate PK/TK, safety, and efficacy of Moderna's drug candidates as needed

• Support lab related activities using current LIMS software and use of AI as appropriate

• Perform method transfer to internal and external stakeholders for qualification/validation  

• Review and author SOPs, relevant protocols, and reports and interact with QAs

• Work closely with colleagues in clinical development organization as well as other cross-functional groups

• Independently serve as an SME representing the BMA team, to support colleagues, from guiding experimental design to analysis and presentation of results

• Provide mass spectrometry support to scientists in Nonclinical, Platform, and other groups 

• Mentor and train the junior members of the group

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

• Ph.D. with least 4+ years or MS with 7+ years of demonstrated hands-on experience with the development and validation of bioanalytical methods using LC-MS (QQQ and or QTRAPs) 

• Hands-on experience with the development of sample preparation/extraction techniques for various analytes from biological matrices such as SPE, LLE, protein precipitation, IP-LCMS/MS

• In-depth knowledge of US, EU regulations, M10 regulations and ICH guidelines. Assist in writing regulatory submissions and in responding to regulatory queries when needed. 

• Experience with Watson LIMS design and data management are preferred

• Experience with metabolite profiling, identification, and characterization of metabolites using High-resolution mass spectrometry (HRMS) – Met ID of small molecules and lipids are preferred.

• Ability to develop and implement methods for high throughput or (semi-)automated data analysis is preferred.

• Willingness to learn new concepts and challenge boundaries; adaptability to change 

• Organization and attention to detail; ability to handle multiple projects in a fast-paced environment 

• Strong interpersonal skills with an eagerness to work with and support colleagues in other departments 

• Proven ability to develop and work independently and to collaborate cross-functionally to accomplish goals in a timely manner

• CROs management experience is preferred

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 yo