R&D + Process Development /Scale-upPharma Sector – State of the Art PlantCompetitive Package on Offer. Gold Coast QldOur 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 activitiesEvaluate process control by statistical analysis from a yield and robustness perspective and identify opportunities for process improvementsAssist with identification of root causes for manufacturing-related deviations by data analysis and providing solutions including corrective and preventative actionsEnsure equipment used for R&D and manufacturing purposes is fit for use and report faults when they occurReview changes that potentially impact intermediate or API qualityThe 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 targetsa proven track record within API development and/or API manufacturing including scale-upexperience in process development and optimisation including the design of experiments and methodologiesexperience in statistical analysis and statistical process controlReporting 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.

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.