About

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.