Director of Analytical Chemistry

MBX Biosciences - Carmel, IN

Full-time - Senior

Carmel, IN

Professional, Scientific, and Technical Services

About the position

MBX Biosciences, Inc. is seeking to hire a Director of Analytical Chemistry who will lead the Analytical Chemistry department, overseeing the development and execution of analytical strategies to support drug discovery, development, and manufacturing in support of our Precision Endocrine Peptide platform. This position requires a deep understanding of peptide chemistry, analytical techniques, and regulatory guidelines to ensure the quality, stability, and safety of novel peptide-based therapeutics. The successful candidate will work cross-functionally with internal teams and external partners to ensure robust analytical methodologies are in place for product development and commercial success.

Responsibilities

• Build, lead, manage, and mentor the Analytical Chemistry team, ensuring the department delivers high-quality analytical data on peptides and other compounds.
• Develop and optimize analytical methods for peptide characterization, including HPLC, LC-MS, NMR, spectroscopy, and other relevant techniques.
• Oversee the establishment of stability protocols, impurity profiling, and characterization of peptides for preclinical, clinical, and commercial stages.
• Ensure compliance with GMP, GLP, and ICH guidelines in all analytical operations, including validation and transfer of methods to CMO and CRO partners.
• Collaborate with formulation, process development, and quality control teams to troubleshoot and resolve analytical challenges.
• Design and implement stability studies for peptide products, ensuring robust data generation to support regulatory filings.
• Support regulatory submissions by providing analytical documentation, method validation reports, and stability data for IND, NDA, and other regulatory filings.
• Stay current with advancements in analytical chemistry, technologies, and regulatory requirements relevant to peptide therapeutics.
• Manage external collaborations and contracts with CROs and CMOs for outsourced analytical services.
• Prepare and present technical reports and data summaries to internal teams, executive leadership, and external regulatory agencies.
• Other responsibilities as assigned.

Requirements

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 10 years of experience in analytical chemistry, with at least 5 years in a leadership role, preferably within the pharmaceutical or biotechnology industry.
• Expertise in peptide analysis, including extensive experience with HPLC, LC-MS, and other peptide-specific analytical methods.
• Strong understanding of regulatory requirements for pharmaceutical product development, including experience with ICH guidelines, GMP, and GLP.
• Proven experience with method development, validation, and transfer in a regulated environment.
• Strong project management skills, with the ability to lead multiple projects and teams simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Experience supporting regulatory filings and audits (IND, NDA, etc.) is a plus.

Nice-to-haves

• Familiarity with peptide formulation and process development.
• Experience in working with external contract research organizations (CROs) and contract manufacturing organizations (CMOs).
• Strong problem-solving skills and the ability to troubleshoot complex analytical challenges.