Description

• ASX-Listed
• Oncology
• Biotech

The Company

Our client is an innovative ASX-listed biotechnology company based in inner Melbourne, with more than 20 years’ experience advancing proprietary dendrimer technology from discovery to clinical application. Its mission is to improve outcomes for patients with serious illnesses, particularly cancer, by developing novel dendrimer-based therapies. The company has achieved strong clinical validation across multiple Phase 2 oncology programs and is advancing a radiopharmaceutical asset towards clinical entry. Through focused asset development and strategic partnerships with leading global pharmaceutical organisations, it is well positioned as a leader in dendrimer-based drug delivery innovation.

The Opportunity 

This is a hands-on, laboratory-based senior scientist role focused on advancing analytical development and CMC activities for complex dendrimer conjugates, including biologic and radiotheranostic components. Reporting to the Director of Translational Science & CMC, you will collaborate across multidisciplinary teams to drive key R&D programs from early discovery through to regulatory submission:

• Lead analytical development, characterisation and lifecycle management of dendrimers and complex dendrimer conjugates using LCMS, HPLC/UHPLC/UPLC, SEC, HIC and related techniques.
• Develop, optimise and troubleshoot phase-appropriate analytical methods, from early fit-for-purpose approaches through to fully validated procedures as programs advance.
• Plan and execute method qualification and validation activities in line with ICH/EMA/FDA guidelines and applicable GxP requirements.
• Prepare high-quality CMC documentation, including method development reports, validation protocols, specification rationales and data summaries, to support regulatory submissions and analytical responses.
• Work with CMC project managers, Quality and Regulatory teams, and external partners to define critical quality attributes, control strategies, impurity profiles and stability-indicating methods for complex dendrimer conjugates.
• Provide scientific input into the selection, qualification and oversight of external analytical laboratories, including scopes of work, protocol review and interpretation of complex data packages.
• Contribute to analytical lifecycle management, including continuous improvement, change control and revalidation of analytical procedures as programs progress through clinical development and towards commercialisation.
• Experience in the analysis and characterisation of complex conjugates used in radiopharmaceutical applications, including precursor and targeting-vector characterisation, is advantageous.
• Identify and assess emerging analytical techniques through literature, conferences and vendor engagement, then design feasibility studies to evaluate their relevance to dendrimer programs.
• Collaborate with Discovery, Cancer Biology, Scale-Up and Development teams to ensure analytical outputs inform translational hypotheses and support progression to GMP scale-up. Mentor junior analysts in practical technique, experimental design, regulatory awareness and scientific problem-solving.
• Support the development and maintenance of a GMP-compliant quality system by authoring and reviewing SOPs, protocols, test methods and specifications.

Requirements

The Requirements

• BSc in Chemistry or Biochemistry with 7–10+ years of analytical method development experience in the pharmaceutical or biotech sector; a higher research degree in analytical chemistry or a related discipline will be well regarded.
• Demonstrated hands-on experience in analytical development and validation for complex modalities, including conjugates, biologic components, macromolecules and/or radiotheranostics.
• Strong proficiency with chromatographic and mass spectrometric techniques (LCMS, HPLC/UHPLC/UPLC), with experience in SEC, HIC and/or other biophysical methods relevant to conjugates and biologics.
• Working knowledge of ICH/EMA/FDA analytical and CMC guidelines (Q2(R2), Q6, Q8–Q10, Q14) and GxP requirements (GLP, GMP and, where applicable, GCP), with demonstrated ability to apply these in a phase-appropriate, risk-based manner.
• Experience contributing to CMC sections of regulatory submissions and responding to analytical questions from regulatory agencies is highly desirable.
• Previous experience in a GMP or GLP-aligned, QA-accredited laboratory supporting drug substance and/or drug product development.
• Familiarity with chromatography data systems such as Waters Empower or Agilent ChemStation.
• Ability to work confidently with proteins and biological fluids; experience with large molecular weight molecules (proteins, antibodies and/or oligonucleotides) is desirable.
• Demonstrated curiosity and initiative in identifying and implementing new analytical approaches, engaging with scientific literature, vendors and external laboratories as needed.
• Excellent written and verbal communication skills, with the ability to produce high-quality technical reports and maintain detailed experimental records.
• Strong interpersonal skills and a genuine commitment to collaborative, cross-functional teamwork.

The Offer

This is a permanent, full-time position offering competitive remuneration including cash and equity-based incentives, a comprehensive health and wellbeing program, and access to quality professional development resources. You will join a close-knit, high-performing team in a Great Place to Work® certified organisation that fosters a collegiate, inclusive and purpose-driven culture in inner Melbourne. For more information, reach out to our team at 1300 063 932 or email Mark Thomas or Marilyn Jones at careers@mexec.com