" \u003cdiv class=\"ja-job-details\"\u003e \u003ch2 class=\"title\"\u003eSenior Scientist\u003c/h2\u003e \u003cdiv class=\"meta\"\u003e \u003cul class=\"classifications\"\u003e \u003cli data-id=\"17130\"\u003e Science \u0026amp; Biotechnology \u003c/li\u003e \u003cli data-id=\"17131\"\u003e Biotech \u003c/li\u003e \u003cli data-id=\"17132\"\u003e Melbourne \u003c/li\u003e \u003cli data-id=\"17133\"\u003e Permanent / Full Time \u003c/li\u003e \u003c/ul\u003e \u003cp class=\"date-posted\"\u003e 28/9/2026 \u003c/p\u003e \u003c/div\u003e \u003cul class=\"bullet-points\"\u003e \u003cli\u003eASX-Listed\u003c/li\u003e \u003cli\u003eOncology\u003c/li\u003e \u003cli\u003eBiotech\u003c/li\u003e \u003c/ul\u003e \u003cdiv class=\"description\"\u003e \u003cstrong\u003eThe Company\u003c/strong\u003e\u003cbr\u003e Our client is an innovative ASX-listed biotechnology company based in inner Melbourne, with more than 20 years\u0026rsquo; 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.\u003cbr\u003e\u003cbr\u003e \u003cstrong\u003eThe Opportunity \u003c/strong\u003e\u003cbr\u003e 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 \u0026amp; CMC, you will collaborate across multidisciplinary teams to drive key R\u0026amp;D programs from early discovery through to regulatory submission:\u003cbr\u003e \u003cul\u003e \u003cli\u003eLead analytical development, characterisation and lifecycle management of dendrimers and complex dendrimer conjugates using LCMS, HPLC/UHPLC/UPLC, SEC, HIC and related techniques.\u003c/li\u003e \u003cli\u003eDevelop, optimise and troubleshoot phase-appropriate analytical methods, from early fit-for-purpose approaches through to fully validated procedures as programs advance.\u003c/li\u003e \u003cli\u003ePlan and execute method qualification and validation activities in line with ICH/EMA/FDA guidelines and applicable GxP requirements.\u003c/li\u003e \u003cli\u003ePrepare high-quality CMC documentation, including method development reports, validation protocols, specification rationales and data summaries, to support regulatory submissions and analytical responses.\u003c/li\u003e \u003cli\u003eWork 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.\u003c/li\u003e \u003cli\u003eProvide scientific input into the selection, qualification and oversight of external analytical laboratories, including scopes of work, protocol review and interpretation of complex data packages.\u003c/li\u003e \u003cli\u003eContribute to analytical lifecycle management, including continuous improvement, change control and revalidation of analytical procedures as programs progress through clinical development and towards commercialisation.\u003c/li\u003e \u003cli\u003eExperience in the analysis and characterisation of complex conjugates used in radiopharmaceutical applications, including precursor and targeting-vector characterisation, is advantageous.\u003c/li\u003e \u003cli\u003eIdentify and assess emerging analytical techniques through literature, conferences and vendor engagement, then design feasibility studies to evaluate their relevance to dendrimer programs.\u003c/li\u003e \u003cli\u003eCollaborate 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.\u003c/li\u003e \u003cli\u003eSupport the development and maintenance of a GMP-compliant quality system by authoring and reviewing SOPs, protocols, test methods and specifications.\u003c/li\u003e \u003c/ul\u003e \u0026nbsp;\u0026nbsp;\u003cbr\u003e \u003cstrong\u003eThe Requirements\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003eBSc in Chemistry or Biochemistry with 7\u0026ndash;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.\u003c/li\u003e \u003cli\u003eDemonstrated hands-on experience in analytical development and validation for complex modalities, including conjugates, biologic components, macromolecules and/or radiotheranostics.\u003c/li\u003e \u003cli\u003eStrong 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.\u003c/li\u003e \u003cli\u003eWorking knowledge of ICH/EMA/FDA analytical and CMC guidelines (Q2(R2), Q6, Q8\u0026ndash;Q10, Q14) and GxP requirements (GLP, GMP and, where applicable, GCP), with demonstrated ability to apply these in a phase-appropriate, risk-based manner.\u003c/li\u003e \u003cli\u003eExperience contributing to CMC sections of regulatory submissions and responding to analytical questions from regulatory agencies is highly desirable.\u003c/li\u003e \u003cli\u003ePrevious experience in a GMP or GLP-aligned, QA-accredited laboratory supporting drug substance and/or drug product development.\u003c/li\u003e \u003cli\u003eFamiliarity with chromatography data systems such as Waters Empower or Agilent ChemStation.\u003c/li\u003e \u003cli\u003eAbility to work confidently with proteins and biological fluids; experience with large molecular weight molecules (proteins, antibodies and/or oligonucleotides) is desirable.\u003c/li\u003e \u003cli\u003eDemonstrated curiosity and initiative in identifying and implementing new analytical approaches, engaging with scientific literature, vendors and external laboratories as needed.\u003c/li\u003e \u003cli\u003eExcellent written and verbal communication skills, with the ability to produce high-quality technical reports and maintain detailed experimental records.\u003c/li\u003e \u003cli\u003eStrong interpersonal skills and a genuine commitment to collaborative, cross-functional teamwork.\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003eThe Offer\u003c/strong\u003e\u003cbr\u003e 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\u0026reg; 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 \u003c/div\u003e \u003cdiv class=\"apply\"\u003e \u003ca class=\"back-link\" href=\"#\" title=\"Back to search results\"\u003eBack to search results\u003c/a\u003e \u003cinput type=\"button\" class=\"ja-button\" data-job-id=\"4474014\" value=\"Apply Now\" title=\"Apply Now\" /\u003e \u003c/div\u003e \u003c/div\u003e "