Research and Development Manager

3 weeks ago

Sydney, New South Wales, Australia Labour Support Group Full time

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Position Title: Research and Development Manager

Mucpharm is a specialised company focused on the treatment of mucin-containing and secreting conditions. Their research and development facility is based in Kogarah, New South Wales where this position will be based at.

About The Role

They are seeking a highly skilled and motivated Analytical Research and Development Manager to lead our Analytical and Bioanalytical functions. This role is responsible for planning, directing, and managing advanced R&D activities for our molecules in alignment with international regulatory standards (TGA, FDA, EMA). The successful candidate will bring extensive hands-on expertise in LC-MS/MS, HPLC, and analytical functions to support in-vitro/in-vivo studies.

This is a full time role with an annual salary set between $100,000 to $120,000 based on experience, plus superannuation. The role is based in Kogarah, New South Wales.

Key Responsibilities

  • Lead the design, development, and validation of analytical and bioanalytical methods for small and large molecules (Proteins and peptides) using LC-MS/MS, HPLC, UPLC-MS/MS, FTIR, and other advanced instrumentation.
  • Manage analytical components of studies including ADME, DMPK, bioavailability/bioequivalence (BA/BE), metabolic stability, CYP inhibition (CYP3A4, CYP2D6), Hepatocytes and plasma protein binding assays for biologics and small molecule drugs.
  • Ensure laboratory practices comply with GLP, and GMP standards and contribute to the analytical components of audit readiness, documentation, SOP compliance, and laboratory safety procedures.
  • Provide scientific and operational leadership ensuring continuous training opportunities for junior team members, mentoring, and professional development.
  • Prepare and oversee preparation of technical reports, validation summaries, and regulatory documentation for TGA, FDA, and EMA submissions.
  • Maintain and calibrate laboratory instruments; manage troubleshooting and ensure equipment readiness for project demands.
  • Collaborate with cross-functional teams, vendors, and regulatory bodies to ensure seamless communication and timely delivery of R&D milestones.
  • Stay updated with scientific advancements and integrate cutting-edge technologies into ongoing and future research strategies.

Essential Requirements
  • Master's degree in Pharmaceutical Sciences or related discipline.
  • Minimum 3 years' experience in analytical R&D, bioanalysis, and method development and validation.
  • Minimum 3 years' experience in analysing ADME, DMPK, metabolic stability, CYP inhibition (CYP3A4, CYP2D6), Hepatocytes and plasma protein
  • Minimum 3 years' experience in with BA/BE, PK/PD, metabolic ID, solubility/permeability, stability studies.
  • Must have clinical experience using LC-MS/MS, HPLC, UPLC-MS/MS, FTIR, and other advanced instrumentation
  • Must have technical report experience for FDA, EMA, TGA meeting regulatory guidelines and documentation.
  • Must have software proficiency in Lab solution Insight Shimadzu, X Caliber software, AB Sciex Analyst
  • Proven track record of managing complex research projects and leading scientific teams.
  • Extensive hands-on experience with bioanalytical platforms and sample matrices including plasma, serum, urine, and tissues.
  • Ability to translate research insights into commercially viable outcomes and drive continuous improvement.
Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionResearch, Analyst, and Information Technology
  • IndustriesHuman Resources Services

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