Bioassay Scientist

<p><strong><u>Position Summary</u></strong> </p> <p>The Scientist, Analytical Development – Bioassay will support the development, qualification, transfer, and lifecycle management of potency assays for peptide therapeutic programs from early clinical to commercial development. This role will focus on the design and execution of cell-based and/or binding bioassays to enable product characterization, release, stability testing, and comparability assessments. The Scientist will work collaboratively with other MBX functions and external CDMO partners to ensure phase-appropriate, scientifically sound, and compliant bioassay strategies are implemented across the portfolio.</p> <p><strong><u>Key Responsibilities</u></strong></p> <ul> <li>Lead development, qualification, and validation of bioassays for release and characterization testing of therapeutic peptide products, ensuring fitness for purpose across clinical and commercial phases both internally and at external vendors.</li> <li>Build and maintain bioassay analytical capabilities at internal lab, train and mentor junior technicians internally and at external partners.</li> <li>Provide technical oversight and manage bioassay development activities at external CROs/CMOs, ensuring data integrity, compliance, and on-time deliverables.</li> <li>Collaborate cross-functionally with Discovery, Pre-Clinical, Quality, and Regulatory teams to ensure potency strategy is aligned with program needs.</li> <li>Author and review biological characterization and testing sections of regulatory filings, including IND, INDa, IMPD, and NDA/BLA submissions.</li> <li>Lead or support investigations for OOT/OOS bioassay results.</li> <li>Stay current with evolving regulatory guidance, pharmacopeial standards, and best practices in potency assay analytical development.</li> <li>Other responsibilities as assigned.</li> </ul> <p><strong><u>Education</u></strong><u> <strong>& Qualifications</strong></u> </p> <ul> <li>Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline with 1+ years, M.S. with 3+ years, B.S. with 5+ years of relevant industry experience.</li> <li>Strong expertise in bioassay methods (ELISA, ligand-binding assays, reporter assays, or other potency platforms) including method development and GxP qualification or validation for either peptide small molecules or protein biologics.</li> <li>Familiarity with regulatory requirements and guidelines (ICH, FDA, EMA, JP) related to cell-based potency assay development and validation.</li> <li>Proven ability to interpret complex analytical data (eg. dose-response modeling, parallel line analysis, 4PL/5PL curve fitting) and apply scientific judgment to development and troubleshooting.</li> <li>Experience managing analytical activities at external partners (CROs/CMOs) and driving cross-functional collaborations preferred.</li> <li>Excellent written and verbal communication skills, including experience authoring GxP method development and qualification documentation.</li> <li>Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.</li> </ul> <p><strong><u>Travel</u></strong></p> <p>You will be expected to travel periodically based on the needs of the business to the extent requested by the Company including attendance at Together Weeks, Together Days and functional meetings as requested by the Company.</p> <p><strong>Company Overview</strong>:</p> <p>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 <a href="http://www.mbxbio.com">www.mbxbio.com </a>and follow us on LinkedIn. </p> <p><strong>EEO Statement: </strong></p> <p>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. </p>