Principal Scientist: Biologics Analytics & Formulation

Januxrx; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Janux Therapeutics, Inc. seeks a Principal Scientist to lead analytical and formulation development for biologics in immuno-oncology and autoimmune disease. You will supervise CDMOs, develop analytical methods, and oversee stability and regulatory activities.

The role emphasizes cross-functional collaboration, mentorship of junior scientists, and hands-on leadership in a fast-paced development environment.

Qualifications

• Ph.D., M.S., or B.S. in relevant field with industry experience.
• Extensive experience in analytical method development, validation, and troubleshooting.
• Proven formulation development experience for protein therapeutics.
• Strong knowledge of FDA/ICH/pharmacopoeia and cGMP guidelines.
• Experience with advanced analytical techniques in biologics.
• Familiarity with QbD and risk-based approaches.
• Experience managing external CROs/CMOs.
• Excellent organizational, written and verbal communication skills.

Responsibilities

• Develop and qualify/validate analytical methods for drug substances/products at CDMOs.
• Design formulation development studies to support preclinical/clinical programs.
• Oversee stability studies and regulatory compliance.
• Provide oversight of reference standard programs.
• Collaborate with Research, Quality, Regulatory Affairs to advance projects.
• Provide technical leadership and mentorship to junior staff.
• Author/review technical reports and regulatory submissions.
• Conduct pre-formulation characterization and formulation studies.
• Develop/implement protocols for analytical method qualification and formulation development.
• Ensure accurate documentation and reporting of activities and results.
• Support compatibility testing of clinical supplies.
• Troubleshoot and resolve lab issues.
• Perform other duties as assigned by management.

Skills

Analytical method development

Regulatory knowledge

Protein formulation

Leadership

CRO/CMO management

QbD principles

Team collaboration

Problem solving

Education

Ph.D.

M.S.

B.S.

Tools

HPLC

Mass spectrometry

Statistical analysis

Job description

Janux Therapeutics, Inc. seeks a Principal Scientist to lead analytical and formulation development for biologics in immuno-oncology and autoimmune disease. You will supervise CDMOs, develop analytical methods, and oversee stability and regulatory activities.

The role emphasizes cross-functional collaboration, mentorship of junior scientists, and hands-on leadership in a fast-paced development environment.