Senior Scientist, mRNA Analytics & Method Development

Sanofi; Waltham (MA); In loco; USD 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

Parental leave (14 weeks)

Career growth opportunities

Descrizione del lavoro

Sanofi is seeking an mRNA Analytical Development Senior Scientist in Waltham, MA. You will develop advanced analytical methods to characterize mRNA vaccines, collaborate with CMC teams, and guide method documentation for regulatory filings, while leading junior scientists and ensuring GMP/HSE compliance.

The role emphasizes LC/biochemical method development, CRO management if needed, and close interaction with bioprocess development to advance vaccine candidates through development and release

Competenze

• PhD or Master’s degree with pharma/biotech experience.
• Experience in CMC analytical development.
• Expertise in LC (RP, IEX, SEC, HILIC) and related techniques.
• Ability to perform complex method development.

Mansioni

• Develop advanced technology for biochemical, biophysical, and bioassay development for mRNA vaccine processes and product development.
• Collaborate with analytical leads supporting CMC activities.
• Write and review method documentation and characterization reports for regulatory filings.
• Independently design and execute complex experiments; author development and investigation reports.
• Manage assay testing at CROs if required and support investigations and change controls.
• Participate in internal non-GMP and GMP lab setup and product release and stability testing.
• Supervise and train junior scientists.
• Ensure compliance with Sanofi Quality standards and HSE policies and drive continuous safety/quality improvements.

Conoscenze

CMC analytical development

LC methods

Method development

GMP knowledge

Formazione

PhD or Master’s in Biochemistry/Analytical

Strumenti

LC-MS

Descrizione del lavoro

Sanofi is seeking an mRNA Analytical Development Senior Scientist in Waltham, MA. You will develop advanced analytical methods to characterize mRNA vaccines, collaborate with CMC teams, and guide method documentation for regulatory filings, while leading junior scientists and ensuring GMP/HSE compliance.

The role emphasizes LC/biochemical method development, CRO management if needed, and close interaction with bioprocess development to advance vaccine candidates through development and release