What are the responsibilities and job description for the Director, Bioanalytical Chemistry position at MBX Biosciences, Inc.?
Position Summary
We are seeking an experienced and dynamic Director of Bioanalytical Chemistry to lead our bioanalytical chemistry team. This role will focus on developing and overseeing bioanalytical strategies to support preclinical and clinical programs for peptide therapeutics. The ideal candidate will have a strong background in bioanalytical method development, regulatory compliance, and team leadership, with a particular emphasis on working with peptide-based drugs.
Key Responsibilities
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.
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.
We are seeking an experienced and dynamic Director of Bioanalytical Chemistry to lead our bioanalytical chemistry team. This role will focus on developing and overseeing bioanalytical strategies to support preclinical and clinical programs for peptide therapeutics. The ideal candidate will have a strong background in bioanalytical method development, regulatory compliance, and team leadership, with a particular emphasis on working with peptide-based drugs.
Key Responsibilities
- Build and lead bioanalytical chemistry team in designing and implementing strategies for quantitative and qualitative analysis of peptides in biological matrices
- Working primarily though external CROs with the expectation that an internal capability will be developed.
- Provide technical and strategic leadership in bioanalytical method development, validation, and sample analysis.
- Oversee developing and validating robust bioanalytical methods for LC-MS/MS, immunoassays, and other techniques to quantify peptides, metabolites, and biomarkers in biological matrices.
- Ensure the bioanalytical methods meet regulatory requirements (e.g., GLP, FDA, EMA guidelines) for preclinical and clinical studies.
- Ensure compliance with regulatory standards and prepare bioanalytical sections for regulatory submissions (IND, NDA, BLA).
- Oversee bioanalytical sample analysis for pharmacokinetics (PK), pharmacodynamics (PD), toxicokinetics (TK), and immunogenicity assessments.
- Support the design and execution of preclinical and clinical studies by providing bioanalytical expertise.
- Address complex bioanalytical challenges, including peptide stability, degradation, and matrix interference issues.
- Other responsibilities as assigned.
- PhD in Bioanalytical Chemistry, Biochemistry, Pharmacology, or a related field; a Master’s degree with significant industry experience will also be considered.
- Minimum of 10 years of experience in bioanalytical chemistry, with at least 5 years in a leadership role in the pharmaceutical or biotechnology industry.
- Expertise in bioanalytical methods for peptides, including LC-MS/MS, immunoassays (e.g., ELISA, MSD), and hybrid approaches.
- Experience working with CROs to develop and support the company’s bioanalytical needs.
- Strong understanding of regulatory requirements for bioanalytical method development, validation, and reporting.
- Demonstrated success in supporting preclinical and clinical programs through bioanalytical strategy and execution.
- Excellent problem-solving skills with a track record of addressing complex bioanalytical challenges.
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.
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.
