Senior Scientist, Drug Substance Development & Scale-Up

MBX Biosciences, Inc.; Burlington (MA); Vor Ort; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

MBX Biosciences, a biopharmaceutical company focused on precision peptide therapies, seeks a Senior Scientist in Drug Substance to lead scalable synthesis of peptide drug substances and intermediates. You will drive late‑stage development, contribute to QbD, and define control strategies aligned with global regulatory expectations.

You will oversee external CDMOs, support tech transfers, and collaborate across Discovery, Analytical Chemistry, Quality, Regulatory CMC, and Clinical teams.

Qualifikationen

• Bachelor0s degree in a chemical/biological field with 7+ years in CMC drug substance development or related area.
• Strong knowledge of peptide drug substance development, manufacturing, process validation and regulatory expectations.
• Experience with external partners (CROs/CMOs) and tech transfers.
• Excellent written and verbal communication skills; ability to author regulatory documentation.

Aufgaben

• Design, optimize synthetic routes for peptide drug substances and intermediates with a focus on scalability and sustainability.
• Develop control strategies aligned with regulatory expectations (ICH Q7, Q11).
• Oversee CDMOs for manufacturing campaigns, releases, tech transfers, investigations.
• Lead process development, scale-up, troubleshooting, and quality-by-design activities.
• Collaborate with Discovery, Analytical Chemistry, Quality, Regulatory CMC, and Clinical teams; manage external consultants.

Ausbildung

Bachelor0s in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 7+ years of industry experience

Jobbeschreibung

MBX Biosciences, a biopharmaceutical company focused on precision peptide therapies, seeks a Senior Scientist in Drug Substance to lead scalable synthesis of peptide drug substances and intermediates. You will drive late‑stage development, contribute to QbD, and define control strategies aligned with global regulatory expectations.

You will oversee external CDMOs, support tech transfers, and collaborate across Discovery, Analytical Chemistry, Quality, Regulatory CMC, and Clinical teams.