Senior Scientist, Analytical Development – Dendrimer Biotech

QCMHR; City of Melbourne; On-site; AUD 130,000 - 180,000; Full time

Benefits offered by this job

Cash and equity incentives

Health & wellbeing program

Professional development

Great Place to Work culture

Job summary

QCMHR in inner Melbourne is seeking a hands-on Senior Scientist to advance analytical development and CMC activities for complex dendrimer conjugates, including biologic and radiotheranostic components. You will lead analytical development and collaborate across translational teams to support regulatory submissions.

The role reports to the Director of Translational Science & CMC, offering a permanent, full-time position with strong remuneration, equity incentives, and a collaborative culture in

Qualifications

• BSc in Chemistry or Biochemistry with 7–10+ years of analytical method development experience in the pharmaceutical or biotech sector.
• Hands-on analytical development and validation for complex modalities including conjugates, biologics and radiotheranostics.
• Strong proficiency with LCMS, HPLC/UHPLC/UPLC; SEC, HIC and related biophysical methods.
• Knowledge of ICH/EMA/FDA analytical and CMC guidelines and GxP requirements.
• Experience contributing to CMC sections of regulatory submissions and regulatory questions.
• GMP/GLP-aligned QA laboratory experience supporting drug substance/product development.

Responsibilities

• Lead analytical development, characterization and lifecycle management of dendrimers and conjugates.
• Develop, optimise and troubleshoot phase-appropriate analytical methods from early fit-for-purpose to validated procedures.
• Plan and execute method qualification and validation in line with guidelines and GxP.
• Prepare CMC documentation to support regulatory submissions and responses.
• Mentor junior analysts and collaborate with regulatory, QA and external labs.

Skills

Analytical method development

LCMS/HPLC expertise

Cross-functional collaboration

Scientific writing

Education

BSc in Chemistry or Biochemistry

Tools

Waters Empower

Agilent ChemStation

Job description

QCMHR in inner Melbourne is seeking a hands-on Senior Scientist to advance analytical development and CMC activities for complex dendrimer conjugates, including biologic and radiotheranostic components. You will lead analytical development and collaborate across translational teams to support regulatory submissions.

The role reports to the Director of Translational Science & CMC, offering a permanent, full-time position with strong remuneration, equity incentives, and a collaborative culture in