MBX Biosciences
Biotech
AssociateDirector,FormulationDevelopment
Neural analysis suggests this role is
optimal for Director candidates.
“Associate Director, Formulation Development at MBX Biosciences. Skills: Formulation development, Peptide therapeutics, Product quality, Stability studies. Lead formulation design. Optimize pharmaceutical formulations”
Industry & Context.
Root cause analyses; Troubleshooting
What They're Looking For.
Must Have
Scientific expertise in peptide formulation, Scientific expertise in protein formulation, Collaboration across cross-functional teams, Collaboration with external partners
Nice to Have
Experience with MBX 4291, Experience with MBX 5765
What You'll Do.
Lead formulation design
Optimize pharmaceutical formulations
Develop pharmaceutical formulations
Oversee formulation development laboratory activities
Support advancement of peptide therapeutics
Support implementation of analytical methods
Characterize peptides
Oversee implementation of QC procedures
Ensure compliance with regulatory guidance
Ensure compliance with industry standards
Plan non-GMP stability studies
Conduct non-GMP stability studies
Contribute to GMP stability study design
Assess degradation pathways
Lead drug product process optimization studies
Contribute to drug product process optimization studies
Enhance product performance
Enhance manufacturability at scale
Contribute to process transfer to CDMOs
Identify formulation technical challenges
Address formulation technical challenges
Identify analytical technical challenges
Address analytical technical challenges
Partner with Regulatory personnel
Ensure appropriate data incorporated into regulatory documents
Ensure information incorporated into regulatory documents
Ensure documentation incorporated into regulatory documents
How You'll Work.
Team & Collaboration
Cross-functional teams; External partners
Full Job Description
Position Summary The Associate Director, Formulation Development will play a key role on MBX Biosciences’ CMC team, supporting the development of peptide therapeutics across our pipeline. Reporting into our Senior Director, Drug Product- this person will lead formulation design and optimization, oversee studies related to product quality and stability, and support development activities from early assessment through manufacturing transfer. The role requires strong scientific expertise in peptide or protein formulation development, collaboration across cross-functional teams and external partners, and a focus on advancing innovative therapies in a fast-paced biotech environment. Key Responsibilities Lead and contribute to the design, development, and optimization of pharmaceutical formulations for MBX’s peptide therapeutics. Oversee formulation development laboratory activities to support the advancement of peptide therapeutics across the MBX portfolio Support implementation of analytical methods for characterizing peptides, including chromatographic techniques, spectroscopic techniques, and physical characterization in conjunction with AD Oversee and ensure the implementation of robust QC procedures and ensure compliance with regulatory guidance and industry standards (e.g., ICH guidelines) Plan and conduct non-GMP stability studies as part of formulation development. Contribute to the GMP stability study design to assess the shelf-life and degradation pathways. Lead and contribute to the design and execution of drug product process optimization studies, to enhance product performance and manufacturability at scale. Contribute to the process transfer to CDMOs Identify and address formulation and analytical technical challenges, e.g., through design experiments, root cause analyses, etc. Partner effectively with MBX Regulatory personnel to ensure appropriate data, information, and documentation related to formulation and analytical methods are incorporated into regul
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