Scientist, Analytical Development
MBX Biosciences, Inc.
5 months ago
On-site
Burlington, MA
Operations
Key Responsibilities
- Perform a range of routine and non-routine analyses of API and Drug Product for peptide portfolio using various pharmaceutical analysis techniques.
- Conduct hands-on method development, optimization, troubleshooting, and routine execution of chromatographic, mass spectrometry, and electrophoretic assays (e.g., RP-HPLC, SEC, IEX, CE-SDS, icIEF, LC-MS).
- Build and maintain internal analytical capabilities for LC/MS/CE platforms, including instrument qualification, maintenance, and training of other staff.
- Provide technical support for analytical development activities at external CROs/CMOs.
- Collaborate cross-functionally with Discovery, Pre-Clinical, Quality, and Regulatory teams.
- Co-author and review analytical method development, validation, and characterization sections of regulatory filings (IND, INDa, IMPD, NDA/BLA).
- Support investigations for OOT/OOS analytical results.
- Stay current with evolving regulatory guidance, pharmacopeial standards, and best practices.
Education & Qualifications / Requirements
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline (1+ years); or M.S. (2+ years); or B.S. (4+ years) relevant industry experience.
- Strong expertise in chromatographic, mass spectrometric, and electrophoretic techniques (HPLC/UPLC, LC-MS, CE) for peptide therapeutics.
- Hands-on mass spectrometry experience for peptide characterization (intact mass, peptide mapping, impurity identification) preferred.
- Familiarity with regulatory requirements and guidelines (ICH, FDA, EMA, JP).
- Ability to interpret complex analytical data and apply scientific judgment.
- Experience with external partners (CROs/CMOs) and cross-functional collaborations preferred.
- Excellent written and verbal communication; ability to author method development/qualification documentation.
- Strong organizational skills; ability to manage multiple priorities in a fast-paced environment.
Travel
- Onsite role with 4–5 days per week at the Burlington site; periodic travel aligned with business needs (e.g., Together Weeks once a quarter, functional/company meetings).
- Perform a range of routine and non-routine analyses of API and Drug Product for peptide portfolio using various pharmaceutical analysis techniques.
- Conduct hands-on method development, optimization, troubleshooting, and routine execution of chromatographic, mass spectrometry, and electrophoretic assays (e.g., RP-HPLC, SEC, IEX, CE-SDS, icIEF, LC-MS).
- Build and maintain internal analytical capabilities for LC/MS/CE platforms, including instrument qualification, maintenance, and training of other staff.
- Provide technical support for analytical development activities at external CROs/CMOs.
- Collaborate cross-functionally with Discovery, Pre-Clinical, Quality, and Regulatory teams.
- Co-author and review analytical method development, validation, and characterization sections of regulatory filings (IND, INDa, IMPD, NDA/BLA).
- Support investigations for OOT/OOS analytical results.
- Stay current with evolving regulatory guidance, pharmacopeial standards, and best practices.
Education & Qualifications / Requirements
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline (1+ years); or M.S. (2+ years); or B.S. (4+ years) relevant industry experience.
- Strong expertise in chromatographic, mass spectrometric, and electrophoretic techniques (HPLC/UPLC, LC-MS, CE) for peptide therapeutics.
- Hands-on mass spectrometry experience for peptide characterization (intact mass, peptide mapping, impurity identification) preferred.
- Familiarity with regulatory requirements and guidelines (ICH, FDA, EMA, JP).
- Ability to interpret complex analytical data and apply scientific judgment.
- Experience with external partners (CROs/CMOs) and cross-functional collaborations preferred.
- Excellent written and verbal communication; ability to author method development/qualification documentation.
- Strong organizational skills; ability to manage multiple priorities in a fast-paced environment.
Travel
- Onsite role with 4–5 days per week at the Burlington site; periodic travel aligned with business needs (e.g., Together Weeks once a quarter, functional/company meetings).