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(Contract) Research Associate, Analytical Operations

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Closing date
Jun 20, 2019

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Job Details

(Contract) Research Associate, Analytical Operations

The Role:

The primary responsibilities of this role will be to support implementation of analytical methods and routine testing messenger RNA therapeutic drug substances and drug products, including both chemical separation and biophysical techniques. The incumbent will be expected to undertake laboratory work to support in-process sample testing, and release and stability testing of critical non-GMP large scale batches including IND enabling drug substance and drug product batches. The analyst will be responsible for generation and maintenance internal documentation including summaries of analysis (SoA), study protocols, MEMOs and reports.

Additional responsibilities include troubleshooting analytical methods when required, trending analytical method performance, and support for drug product non-GMP/GMP investigations. This position will support cross-functional teams in Research and Development, Production and Quality.

This role will be mainly located in Cambridge, MA. The anticipated time for this assignment is 7 months.

Here's What You'll Do:
  • Support project specific studies by direct interaction with internal stake holders to coordinate product release testing, SoA generation and stability management.
  • Undertake analytical testing using established methods to generate high quality data to support drug product and drug substance release and stability evaluation.
  • Support implementation of new assays from analytical development, test method generation and SME responsibilities supporting method transfers to QC.
  • Generation of internal documentation including SoAs, stability protocols, test method revisions and reports.
  • Troubleshoot analytical instrumentation and methods as required, and trending analytical method performance.
  • Maintain good GLP lab and documentation practices.
  • Provide summary presentations and detailed reports to internal and external stake holders.


Here's What You'll Bring to the Table:
  • BS with 1-3 years or MS with 0-2 years of relevant industry experience.
  • BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
  • Knowledge and extensive hands-on experience of HPLC and modes of separation (e.g. ion exchange, reverse phase ion pairing, size exclusion). Knowledge of biophysical techniques, GC/MS and LC/MS is a plus.
  • Knowledge and extensive hands-on experience of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Empower and Openlab).
  • Familiarity with electronic notebooks, LES and LIMS
  • Knowledge of nucleic acid chemistry and biology and standard methods of analysis of these molecules.


Why join Moderna Therapeutics

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-DNI

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 person's 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.

Company

Moderna is a clinical stage pioneer of messenger RNA (mRNA) Therapeutics™, an entirely new in vivo drug technology that directs the body’s cells to produces human proteins, antibodies and novel protein constructs, which are in turn secreted or active intracellularly. Founded in 2011, we are headquartered in Cambridge, Mass. 

Our Team and Mission

We currently have over 500 team members, an exceptional group of scientists and industry professionals who are wholly committed to advancing Moderna’s mission:  deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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