Director, Bioanalysis & PK/PD for Precision Peptides

MBX Biosciences, Inc.; Burlington (MA); Hybrid; USD 190,000 - 290,000; Full time

Benefits offered by this job

Hybrid work schedule

Competitive compensation

Job summary

MBX Biosciences, Inc. is seeking a senior leader to head bioanalytical develop- ment across discovery, preclinical, and clinical programs. You will guide LC-MS/MS, biomarker assays, and immunogenicity testing, ensuring robust method development, validation, and regulatory readiness.

You will partner with Research, Clinical Development, Regulatory, and Quality to drive strategy, oversee CROs, and deliver high-quality data for INDs and NDAs in a fast-growing, hybrid environment in the Boston area.

Qualifications

• MS with 9+ years of bioanalytical experience; PhD with 7+ years preferred.
• Deep expertise in LC-MS/MS, biomarkers, and immunogenicity testing.
• Proven capability in method development and GMP-compliant validation.
• Strong knowledge of GLP, GCLP and ICH M10 for regulatory submissions.
• Experience managing CROs and external labs; vendor governance.

Responsibilities

• Provide strategic leadership for bioanalytical assay development and validation.
• Lead PK/PD, immunogenicity, and biomarker assessments across the portfolio.
• Develop phase-appropriate bioanalytical strategies compliant with global regulations.
• Serve as bioanalytical SME on cross-functional program teams.
• Oversee CROs and labs to ensure data quality, timelines, and budgets.
• Drive regulatory submissions and responses to health authorities.

Skills

LC-MS/MS

Biomarker assays

Immunogenicity testing

Leadership

Regulatory guidance ICH M10

Cross-functional collaboration

Strategic communication

Education

MS in Bio/Pharma

PhD in a relevant field

Tools

CRO management

Job description

MBX Biosciences, Inc. is seeking a senior leader to head bioanalytical develop- ment across discovery, preclinical, and clinical programs. You will guide LC-MS/MS, biomarker assays, and immunogenicity testing, ensuring robust method development, validation, and regulatory readiness.

You will partner with Research, Clinical Development, Regulatory, and Quality to drive strategy, oversee CROs, and deliver high-quality data for INDs and NDAs in a fast-growing, hybrid environment in the Boston area.