Scientist, Analytical Development

The Role:

The primary responsibilities of this role will be to support early to late phase development, technical management of CRO/CMO, conduct data mining/trending and statistical analysis generated with analytical methods for raw materials lipid, plasmid, enzyme. The incumbent will be expected to think scientifically and undertake detail-oriented activities to support external contract organizations and internal Analytical Development Group. Additional responsibilities include creating and developing analytical strategies and collaborate with cross-functional teams in Analytical Development, Process Development, Production, Clinical Operations, Regulatory Affairs and Quality. This is a non-laboratory management-oriented scientific position in the Analytical Development group.

Heres What Youll Do:

• Undertake technical management for analytical testing to support multitude of activities in early to late phase development

• Undertake technical management for analytical testing at external CRO/CMO

• Create, track, and manage technical deliverables and activities for project milestones

• Build strong knowledge of synthetic chemistry for small molecules to support lipid projects

• Scientifically evaluate needs of lipid project and create deliverables

• Undertake detail-oriented work to mine data, trend, statistically evaluate for assay performance and integrity of results

• Contribute to strategy, review and management of qualification/validation protocols and reports utilizing ICH/Regulatory guidance from external CRO/CMOs

• Work with various SMEs within the Analytical team to identify the need for new method development, create deliverables, troubleshoot assays, track, and manage

• Provide summary presentations and detailed reports to internal and external stake holders

• Provide subject matter expertise to support major lipid, plasmid, enzyme projects

• Generate high quality documentation to support regulatory filings, specification documents including justification of specification, technical protocols, and reports

Heres What Youll Bring to the Table:

• PhD or MS/BS in Medicinal Chemistry, Analytical Chemistry, Biochemistry, or closely related field.

• PhD with 0-2 years or MS with 5-8 years or BS with 8-10 years of relevant academic/industry experience in medicinal or analytical chemistry.

• Knowledge of chromatographic separation, impurity characterization, and spectrophotometric techniques, equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, ChemStation, Empower).

• Knowledge of lipids, small molecules, nanoparticle drug products, liposomal products, nucleic acid chemistry and biology and standard methods of analysis of these molecules is a plus.

• Hands on industry experience with analytical development for small molecules, lipids, nanoparticles, RNA and DNA therapeutics.

• Knowledge in small molecule synthesis is a plus and preferred.

• Knowledge of statistical analysis is a plus.

• Experience in early to mid-phase development: Experience in late phase development is a plus.

• Knowledge of GMP and ICH guidance documents.

• Knowledge of late phase validation and/or early phase qualification of methods.

• Experience authoring technical development reports, IND or other is a plus.

• Highly self-motivated, driven, can-do, make it happen attitude with ability to own and drive major projects.

• Strong collaborator with cross-functional teams and external partners.

• Continuous learning, open-minded, curious, highly organized, thorough, relentless, diligent, detail oriented.

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
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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