
Senior Scientist
- R&D + Process Development /Scale-up
- Pharma Sector – State of the Art Plant
- Competitive Package on Offer. Gold Coast Qld
Our client has a modern international standard (volume & quality) processing facility and on-site lab producing medicinal products under TGA (GMP) licences.
Processing outputs will be increasing gradually over the next 6 months and significantly more in the 12 months beyond this initial ramp-up. The senior scientist will play an integral and critical part in delivering this growth program.
The role is responsible for key aspects of R&D activities principally supporting the introduction of new products into the company’s product portfolio. This will include evaluation of proposed changes in existing product, process and/or equipment and record change controls as per the Quality System. Specific duties include:
- Assist with validation activities, including equipment, process and cleaning validations and creation of respective validation documents.
- Create Batch Manufacturing Records and Standard Operating Procedures for new processes based on process development activities
- Evaluate process control by statistical analysis from a yield and robustness perspective and identify opportunities for process improvements
- Assist with identification of root causes for manufacturing-related deviations by data analysis and providing solutions including corrective and preventative actions
- Ensure equipment used for R&D and manufacturing purposes is fit for use and report faults when they occur
- Review changes that potentially impact intermediate or API quality
The role will require tertiary qualifications in Chemistry, Science or related, with extensive experience in a GMP environment. Additional background required include:
- experience in planning and organising individual work tasks to meet process development and production targets
- a proven track record within API development and/or API manufacturing including scale-up
- experience in process development and optimisation including the design of experiments and methodologies
- experience in statistical analysis and statistical process control
Reporting to the API Manager and working as part of a small team this role is deeply involved in the organisation achieving its product and production targets and will reward initiative with job autonomy.
A competitive package and relocation assistance is offered
Applications quoting Ref No: Q602 should be forwarded to Ross Bell.
Initial enquiries on 0418 450 024 or simply click on the ‘Apply Now’ button.