Senior Scientist, Protein & Peptide/Chemical-Protein Conjugate Formulation

Key Responsibilities

• Design and optimize formulations for proteins and peptide/chemical-protein conjugates (liquid, long-acting, oral and high-concentration)
• Develop formulation strategies that address stability, aggregation, degradation, and delivery challenges
• Support route of administration and dosage form selection for subcutaneous and oral routes
• Lead formulation risk assessments and mitigation strategies

Biophysical & Analytical Characterization

• Apply biophysical techniques to assess stability and developability (e.g., DSC, DLS, CD, SEC, HIC, rheology, subvisible particles)
• Interpret stress and forced degradation data to guide formulation decisions
• Collaborate with analytical teams on method development and comparability

Program & Cross-Functional Leadership

• Serve as formulation lead on cross-functional project teams
• Provide formulation input to candidate selection and early CMC strategy
• Support tech transfer to development, manufacturing, and external partners
• Contribute to IND-enabling and regulatory documentation (CMC sections)

Mentorship & Scientific Leadership

• Mentor junior formulation and analytical scientists
• Establish best practices, workflows, and technical standards
• Act as a subject-matter expert in internal reviews and governance forums

External Collaboration

• Manage and oversee formulation activities with CROs and CDMOs
• Evaluate new formulation technologies and excipient strategies
• Stay current with advances in protein and peptide formulation science

Required Qualifications

• PhD in pharmaceutical sciences, chemical engineering, biochemistry, or related discipline
• 5–10+ years of industry experience in protein and/or peptide formulation
• Deep expertise in biologics and drug-conjugates formulation and stability science
• Experience with high-concentration formulations and/or long-acting injectables
• Experience with oral delivery formulations
• Proven track record supporting clinical candidates
• Strong experimental design, data interpretation, and problem-solving skills

Preferred Qualifications

• Familiarity with device compatibility and combination products
• Familiarity with Auntie and Big Tuna and other Unchained analytical tools
• Experience with global regulatory filings (IND/IMPD)
• Prior experience in biotech or fast-paced development environments