Senior Scientist, mRNA Analytical Development & Methods

Sanofi Group; Waltham (MA); In loco; USD 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

Sanofi Pasteur in Waltham, MA is seeking a Senior Scientist to advance analytical development for mRNA vaccine candidates. You will design and implement advanced biochemical and biophysical assays, support product release and stability studies, and work closely with bioprocess development and regulatory teams.

The role demands deep experience in CMC analytics, method development, and data interpretation, with opportunities to mentor junior scientists and contribute to continuous improvement of

Competenze

• PhD or Master’s degree in Biochemistry, Biology, Cell Biology, Analytical Chemistry, Biotechnology or related sciences.
• Experience in pharmaceutical/biotech analytical development, including CMC aspects.
• Strong capability to develop and optimize analytical methods for nucleic-acid based products.

Mansioni

• Develop advanced technology for biochemical, biophysical, and bioassay method development in support of mRNA vaccine process and product development, release, stability, and comparability studies.
• Collaborate with analytical leads supporting CMC activities.
• Write and review method documentation and characterization reports for regulatory filings.
• Ensure timely completion of assignments; independently design and execute complex experiments; author development and investigation reports.
• Manage assay testing at CROs if required; support investigations, deviations, and change control.
• Participate in non-GMP and GMP lab setup, product release and stability testing.
• Supervise and train junior scientists.
• Comply with Sanofi Quality standards and HSE policy; contribute to lab safety and quality improvements.

Conoscenze

CMC analytical development

Complex method development

Regulatory documentation

Mentorship

Formazione

PhD in Biochemistry/related

Master's in Biochemistry/related

Strumenti

LC-MS

CGE

Descrizione del lavoro

Sanofi Pasteur in Waltham, MA is seeking a Senior Scientist to advance analytical development for mRNA vaccine candidates. You will design and implement advanced biochemical and biophysical assays, support product release and stability studies, and work closely with bioprocess development and regulatory teams.

The role demands deep experience in CMC analytics, method development, and data interpretation, with opportunities to mentor junior scientists and contribute to continuous improvement of