Principal Scientist, Analytical Project Lead - Peptides

Role Summary

Principal Scientist, Analytical Project Lead - Peptides. Lead analytical strategies for synthetic peptide drug substance development, collaborating with project teams and mentoring others to ensure quality and regulatory readiness.

Responsibilities

• Develop analytical strategies in support of synthetic peptide drug substance across all development phases, including manufacturing process development, starting material assessment, method development/validation/transfer, stability studies, and impurity control strategies; author regulatory documentation.
• Plan, direct, and review laboratory work in a matrix environment; oversee lab activities and provide scientific direction.
• Collaborate with internal and external partners to identify analytical approaches, including use of computational tools, modeling software, and data visualization as appropriate.
• Interpret scientific data to derive conclusions, guide future work, and communicate results through presentations and technical reports.
• Evaluate new analytical approaches, instrumentation, or technologies and mentor other scientists.
• Author relevant sections of quality modules for regulatory submissions.

Qualifications

• Ph.D in Analytical Chemistry or related field with 4+ years of R&D experience, or MSc with 9+ years of R&D experience.
• Demonstrated oral and written communication skills, including data visualization, presentations, and authoring technical articles.
• Ability to meet timelines and work with multidisciplinary teams; able to learn new techniques and solve complex analytical problems.
• Attention to detail, strong organizational and interpersonal skills; proficient with a wide variety of software and information systems.

Preferred Qualifications

• Experience with analytical aspects of synthetic peptide modalities, including advanced chromatographic analysis and method development; knowledge of MS, NMR, AAA, ICP-MS, GC, and higher order structure techniques (CD, MALS, etc.).
• Understanding of impurity control strategies for synthetic peptides and structural elucidation of peptide-related impurities.
• Experience authoring and defending analytical strategies in regulatory submissions; leadership experience influencing and coaching others; ability to oversee work to create business impact.
• Knowledge of stage-appropriate method development and related regulatory considerations.

Skills

• Analytical control strategies and techniques for peptide drug substance development
• Chromatography, mass spectrometry, NMR, and related analytical methodologies
• Regulatory documentation and quality module authoring
• Data analysis, modeling, and data visualization
• Mentoring and leadership within a matrix organization

Education

• Ph.D in Analytical Chemistry or related field (or MSc with substantial experience)

Additional Requirements

• Travel may be required; relocation support available.
• On-premise work location.