Director, Bioanalytical

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

Working with Us

MBX Biosciences is a clinical-stage biopharmaceutical company headquartered in Carmel, Indiana, with a secondary office in Burlington, MA. Our mission is to transform the lives of people impacted by endocrine and metabolic disorders through our novel precision peptides. Leveraging our proprietary Precision Endocrine Peptides (PEPs)™ platform, we are pioneering technology designed to overcome key limitations of existing therapies and enhance efficacy, tolerability, safety and convenience. Our team is advancing a pipeline of novel candidates with clinically validated targets, established endpoints for regulatory approval, and strong market potential. Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform. If you’re passionate about advancing innovative treatments for patients and shaping the future of precision peptide therapeutics, this is your chance to make a real impact alongside a fast-paced, growing, mission-driven team. To learn more, visit our website mbxbio.com and follow us on LinkedIn.

What You’ll Do

• Provide strategic leadership for bioanalytical assay development, validation, transfer, and execution to support discovery, preclinical, and clinical-stage peptide therapeutic programs.
• Lead bioanalytical activities for pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity (ADA/NAb), and biomarker assessments across MBX's endocrine and metabolic disease portfolio.
• Develop and implement phase-appropriate bioanalytical strategies that ensure compliance with FDA, EMA, ICH, and other global regulatory requirements.
• Serve as the bioanalytical subject matter expert on cross-functional project teams, partnering closely with Research, Clinical Development, Clinical Pharmacology, Regulatory Affairs, CMC, and Quality functions.
• Oversee external CROs and laboratory partners, ensuring high-quality data delivery, adherence to timelines, budget management, and operational excellence.
• Review, interpret, and communicate bioanalytical, PK, immunogenicity, and biomarker data to support key development, regulatory, and portfolio decision-making.
• Drive authoring and review of regulatory submissions and supporting documentation, including INDs, clinical study reports, bioanalytical reports, and responses to health authority inquiries.
• Build, mentor, and develop high-performing bioanalytical teams while fostering a culture of scientific rigor, collaboration, innovation, and continuous improvement.
• Identify and implement emerging bioanalytical technologies and best practices to enhance data quality, operational efficiency, and the successful advancement of MBX's precision peptide therapies.
• Other responsibilities as assigned.

What You Bring

• MS with 9+ years of experience or PhD in a relevant field with 7+ years of bioanalytical experience in biotech/pharma, including leadership responsibility supporting preclinical and clinical development programs.
• Deep expertise in LC-MS/MS, biomarker assays, and immunogenicity testing for peptides and small molecules.
• Proven experience in bioanalytical method development and validation.
• Strong knowledge of GLP, GCLP and bioanalytical regulatory guidance (ICH M10) and experience supporting regulatory submissions.
• Experience managing CROs and external bioanalytical laboratories, including assay transfer, validation oversight, troubleshooting and vendor governance.
• Demonstrated leadership in supporting early and late-stage clinical development programs, including Phase I–III studies and IND/BLA/NDA support.
• Experience with metabolic disease, obesity, endocrinology, and peptide therapeutics is highly desirable.
• Excellent strategic communication and data interpretation skills, including presentation to executive leadership, health authorities, and external partners.
• Proven people-management and organizational leadership capability, including mentoring scientists and building scalable bioanalytical operations in a growth-stage biotech environment.

Travel & In Office Presence

You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.

EEO Statement

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.