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Sr. Scientist, Bioanalytical and Molecular Assays
3 months ago
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 Programsunder 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 candidatesas 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 with7+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 analysisis 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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