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Manager, Analytical Development

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Nov 6, 2022

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Job Details

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 lipid raw materials (primarily), mRNA drug substance and lipid nanoparticle drug products. The incumbent will be expected to be very scientifically thinking and undertake very detail-oriented work to support external contract organizations and internal work. Additional responsibilities include creating and developing analytical strategies and collaborate with cross-functional teams in Analytical Development, Process Development, Production, Clinical Ops., Reg. Affairs and Quality. This is a non-laboratory management-oriented scientific position in the Analytical 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 very detail-oriented work to mine data, trend them, statistically evaluate them for assay performance and integrity of results

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

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

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

  • Provide subject matter expertise to support major lipid projects.

  • Generate high quality documentation to support regulatory filings be it brief or comprehensive technical protocols and reports, IND modules.

Heres What Youll Bring to the Table:

  • BS with 8-10 years or MS with 5-8 years of relevant industry experience in analytical chemistry.

  • BS/MS in Chemistry, Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.

  • Knowledge of chromatographic separation, biophysical 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 is 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 winter shut down
    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.

#LI-KP1

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Find Us
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States
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