Senior Scientist, Peptide Drug Substance Development

MBX Biosciences, Inc.; Burlington (MA); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

MBX Biosciences, Inc. seeks a Senior Scientist, Drug Substance to drive scalable, sustainable synthetic routes for MBX’s peptide drug substances and intermediates.

You will support late-stage development, contribute to QbD initiatives, and help define control strategies aligned with global regulatory expectations. You’ll provide technical leadership for external CDMOs, support manufacturing campaigns, tech transfers, and investigations, collaborating with Discovery, Analytical Chemistry,

Qualifikationen

• Bachelor-level degree with 7+ years in CMC drug substance development or MS/PhD with 5+ years in CMC drug substance.
• Strong expertise in peptide drug substance development, manufacturing, and process optimization.
• Experience drafting regulatory submissions (IND/ NDA/ MAA) and working with global regulatory requirements.

Aufgaben

• Design, develop, and optimize synthetic routes for MBX peptide drug substances and intermediates.
• Lead CDMO oversight, tech transfers, troubleshooting, and investigations.
• Contribute to QbD initiatives, risk assessments, and CQAs for late-stage development.
• Support process engineering, scale-up, and safety studies in collaboration with internal/external experts.
• Prepare specifications, analytical methods, stability protocols, and master batch records.

Kenntnisse

Peptide drug substance dev

Process characterization

Technical transfers

Regulatory submissions

Ausbildung

Bachelor in Chemistry/Biochemistry/Pharmaceutical Sciences

MS or PhD in CMC or related field

Jobbeschreibung

MBX Biosciences, Inc. seeks a Senior Scientist, Drug Substance to drive scalable, sustainable synthetic routes for MBX’s peptide drug substances and intermediates.

You will support late-stage development, contribute to QbD initiatives, and help define control strategies aligned with global regulatory expectations. You’ll provide technical leadership for external CDMOs, support manufacturing campaigns, tech transfers, and investigations, collaborating with Discovery, Analytical Chemistry,