Senior Scientist
2 weeks ago
Position Summary:
We are looking for a practical, detail-oriented and hands-on Senior Scientist to support the direct formulation and process development activities of novel clinical trial candidates, including complex formulations such as liquid emulsions and nanoparticulate injectables. . The role is team-based and contributes to the efficiency and effectiveness of our daily operations.
Key Responsibilities:
● Develop formulations and processes for complex injectable, topical, solid and liquid oral dosage forms using QbD principles to produce safe and robust clinical trial drug candidates.
● Perform physicochemical testing for characterisation of critical formulation attributes
● Compile, analyse and report data produced in support of the formulation and process development activities.
● Perform equipment calibration, qualification, cleaning and preventative maintenance activities as required.
● Perform the preparation, manufacture, packaging and labelling of pilot scale batches for investigation, stability testing and clinical supply purposes.
● Document all work accurately and completely in compliance to GDP for handover to internal and external customers
● Create, review or update documentation to support product development activities, including Standard Operating Procedures, Work Instructions and Batch Records.
● Perform all activities according to relevant regulations and procedures and contribute to investigations, deviations and change control activities as appropriate.
● Train and assist in the development of other laboratory personnel as required.
● Identify improvements to ensure the safe and efficient operation of the laboratory.
● Keep up to date with training in relevant SOPs and relevant laboratory systems and procedures
Experience, Qualifications and Skills:
● Minimum of a Bachelor's Degree in Chemistry, Formulation Science, Pharmaceutical Sciences or a related Life Science
● At least 5 years' experience in the biotech or pharmaceutical industry
● Good understanding of Quality by Design principles, PIC/S and relevant ICH guidelines
● Experience with the development of complex formulations like emulsions, liposomes or other nanoparticulate systems.
● Familiar with physical characterisation techniques such as particle sizing and rheometry
● Excellent problem solving and analytical thinking skills and able to be creative within an entrepreneurial environment
● Excellent organisational skills and interpersonal skills, enabling interaction with colleagues at all levels within and outside the organisation.
● Excellent written and verbal English communication skills
● Experience with Microsoft applications (Office, Word, Excel, Powerpoint)
