Position Summary:

We are seeking a highly talented Senior Formulation Scientist with a can-do, results-driven attitude to perform formulation and process development activities for novel clinical trial candidates, including complex formulations such as liquid emulsions, nanoparticulate injectables, topical and solid oral dosage forms. Our ideal candidate will be a highly motivated key member of the Product Development team who is adept to working in a fast-paced, collaborative environment within a small team, contributing to the efficiency and effectiveness of our daily operations.

Key Responsibilities:

• Leading and managing assigned projects, ensuring timelines, milestones and customer expectations are met.

• Developing formulations and processes for complex injectable, topical and solid oral dosage forms following QbD principles to produce safe, robust products for clinical trials.

• Performing physicochemical testing to characterize critical formulation attributes.

• Documenting all work accurately and completely in compliance with GDP for handover to internal and external customers.

• Compiling, analysing and reporting data produced in support of formulation and process development activities for regulatory submission.

• Performing equipment calibration, qualification, cleaning and preventative maintenance activities.

• Contributing to the preparation and manufacture, packaging and labelling of pilot scale batches for development, stability testing and clinical supply purposes.

• Creating, reviewing and updating documentation to support product development activities, including Standard Operating Procedures (SOPs) and Batch Records.

• Performing all activities in accordance with relevant regulations and procedures and contributing to investigations, deviations and change control activities as required.

• Training and assisting in the development of other laboratory personnel as required.

• Identifying improvements to ensure the safe and efficient operation of the laboratory.

• Complying with all laboratory and site process training requirements. SOPs and relevant laboratory systems and procedures 

Experience, Qualifications and Skills:

• Minimum of a Bachelor’s degree in Science, Formulation Science, Pharmaceutical Sciences or a related Life Science.

• At least 5 years’ experience in the biotech or pharmaceutical industry, preferably in a Product Development environment.

• Experience with the development of complex formulations such as emulsions, liposomes and/or solid oral dosage forms will be desirable.

• Good understanding of Quality by Design principles, PIC/S, ICH guidelines and Australian Clinical Trial regulations.

• Familiarity with physical/chemical characterisation techniques such as particle sizing, rheometry and HPLC/UPLC.

• Excellent problem solving and analytical skills with an ability to be creative within an entrepreneurial environment.

• Excellent organisational and interpersonal skills, enabling interaction with colleagues at all levels within and outside the organisation.

• Excellent written and verbal communication skills.

• Proficient with Microsoft applications (Office, Word, Excel, PowerPoint).