MBX Biosciences

Biotech

AssociateDirector,FormulationDevelopment

$175–250k ~AI est. Indianapolis, Indiana, United States
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Associate Director, Formulation Development at MBX Biosciences. Skills: Formulation development, Peptide therapeutics, Product quality, Stability studies. Lead formulation design. Optimize pharmaceutical formulations”

Industry & Context.

Biotech
Problems you'll solve

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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