QC Analytical Technology Scientists x 3

Currently recruiting 3 x QC Analytical Technology Scientists - 1 in Biochemistry, 1 in Chemistry and 1 in Microbiology for 12 month, full-time assignments with CSL Location: Broadmeadows.

Please see individual job descriptions below:

Job Title: QC Analytical Technology Scientist (Biochemistry)

Position Title: QC Analytical Technology Scientist (Biochemistry)

Number of Vacancies: 1

Start Date: 15/1/2024

End Date: 12 months

Minimum Education: Bachelor's Degree in Biochemistry and Molecular Biology or in a relevant scientific discipline (Biology, Chemistry, etc.). Relevant post-graduate qualification (Masters or

Job Description: We are looking for a Scientist to join CSL Behring Quality Control Analytical Technologies (QCAT) Biochemistry team at Broadmeadows site (Australia).Reporting to the Head of QCAT you will be responsible for the management and delivery of small projects and project deliverables. You will develop and coordinate associated experimental and documentation activities to ensure timely communication and completion of deliverables, while working in accordance with the Code of Good Manufacturing Practice and data integrity principles.

Must Haves:

• Bachelor's Degree in Biochemistry and Molecular Biology or in a relevant scientific discipline (Biology, Chemistry, etc.). Relevant post-graduate qualification (Masters or Doctorate degree) is preferred.
• A minimum of 2 years' experience in cGMP Quality Control or at least 1 year's experience in method development or method validation for the assessment of biological pharmaceutical products, or equivalent postgraduate experience.
• Experience in ELISA, Electrophoresis, or Endotoxin testing is a plus.
• Postgraduates will be looked upon favorably for this position.

Role:

• Development and validation of methods specific to biochemistry.
• Responsible for the management and delivery of small projects and project deliverables.
• Develop and coordinate associated experimental and documentation activities to ensure timely communication and completion of deliverables, while working in accordance with the Code of Good Manufacturing Practice and data integrity principles.
• Ability to operate independently and as part of a team.
• Flexibility to manage changing priorities.
• Responsible for the development of experimental plans, including estimating materials, resources, and times required for identified work.
• Provide project coordination of method development, validation, and transfer activities.
• Author, review, and update protocols, reports, test procedures, and associated documentation in the performance of experimental studies required.
• Active participation in project meetings, investigations, and regulatory submissions as required.
• Execute appropriate testing and experimental plans as required.
• Ensure efficient, precise, and accurate reporting of test results according to data integrity principles.
• Complete other duties assigned by the reporting manager or delegate.

Location: Broadmeadows

Team Size: 12 employees, plus 7 CWs, plus 10-15 others in the execution of the role.

Flexibility: Potential for some flexibility, possibly one day per week from home.

Hours: 38 hrs per week, standard Mon to Fri, 9 am to 5 pm.

Overtime: If the person works more than 38 hours in the week, approval is required, and penalty rates for overtime are applicable.

Potential to Extend: Too early to say.

Reports to: Head of QCAT

Candidates must have sufficient work rights to be able to work in the position for a minimum of 12 months.

Job Title: QC Analytical Technology Scientist (Microbiology)

Position Title: QC Analytical Technology Scientist (Microbiology)

Number of Vacancies: 3

Start Date: 15/1/2024

End Date: 12 months

Minimum Education: Bachelor's Degree in Microbiology or in a relevant scientific discipline (Biology, etc.). Relevant post-graduate qualification (Masters or Doctorate degree) is preferred.

Must Haves:

• Bachelor's Degree in Microbiology or in a relevant scientific discipline (Biology, etc.). Relevant post-graduate qualification (Masters or Doctorate degree) is preferred.
• A minimum of 2 years' experience in cGMP Quality Control or at least 1 year's experience in method development or method validation for the assessment of biological pharmaceutical products, or equivalent postgraduate experience.
• Experience in cGMP quality control microbiology (bioburden) and/or sterility testing is essential.
• Postgraduates will be looked upon favourably for this position.

Role:

• Responsible for the management and delivery of small projects and project deliverables.
• Develop and coordinate associated experimental and documentation activities to ensure timely communication and completion of deliverables, while working in accordance with the Code of Good Manufacturing Practice and data integrity principles.
• Ability to operate independently and as part of a team.
• Flexibility to manage changing priorities.
• Responsible for the development of experimental plans, including estimating materials, resources, and times required for identified work.
• Provide project coordination of method development, validation, and transfer activities.
• Author, review, and update protocols, reports, test procedures, and associated documentation in the performance of experimental studies required.
• Active participation in project meetings, investigations, and regulatory submissions as required.
• Execute appropriate testing and experimental plans as required.
• Ensure efficient, precise, and accurate reporting of test results according to data integrity principles.
• Complete other duties assigned by the reporting manager or delegate.

Location: Broadmeadows

Team Size: 12 employees, plus 7 CWs, plus 10-15 others in the execution of the role.

Flexibility: Potential for some flexibility, possibly one day per week from home.

Hours: 38 hrs per week, standard Mon to Fri, 9 am to 5 pm.

Overtime: If the person works more than 38 hours in the week, approval is required, and penalty rates for overtime are applicable.

Potential to Extend: Too early to say.

Reports to: Head of QCAT (AU) and Head of QC in Bern

Candidates must have sufficient work rights to be able to work in the position for a minimum of 12 months.

Job Title: QC Analytical Technology Scientist (Chemistry)

Position Title: QC Analytical Technology Scientist (Chemistry)

Number of Vacancies: 1

Start Date: 15/1/2024

End Date: 12 months

Minimum Education: Tertiary qualification in Applied Sciences (Chemistry or Pharmacy)

Must Haves:

• Minimum 5 years of experience in QC or method validation environment is needed.
• Experience in:
• Chromatography (LC, GC)
• Spectroscopy (AAS, UV, Raman)
• Titrimetry
• Direct Instrumental Measurements (pH, Conductivity, Density, Osmolality)
• Nitrogen Determination by Combustion

Role:

• Development, optimization, and/or validation of Chemistry-related methods, including the execution of method transfers between CSL sites/areas and external laboratories as required.
• Carry out the necessary activities to implement these methods and innovative technologies as well as participate in remediating analytical challenges within CSL's Chemistry laboratory.
• Design experimental plans, including estimated materials, times, and resources required for the identified work.
• Preparation, review, and update of standard operating procedures, test procedures, protocols, reports, formal presentations of findings, and other associated documentation in the performance of QCAT studies and investigations are expected, following CSL's documentation and data integrity requirements associated with the generation, review, and reporting of cGMP activities.
• Support the project coordination of QCAT activities by achieving the assigned project deliverables as required through collaboration, under the general guidance of the Head of QCAT or delegate.
• Contribute to the subject matter expertise during the investigation of deviations, atypical results, and method performance issues.
• Provide colleagues with technical assistance, scientific support, and training as required.

Location: Broadmeadows

Team Size: 12 employees, plus 7 CWs, plus 10-15 others in the execution of the role.

Flexibility: Possible occasional work from home, e.g., one day per week.

Hours: 38 hrs per week, standard Mon to Fri, 9 am to 5 pm.

Overtime: If the person works more than 38 hours in the week, approval is required, and penalty rates for overtime are applicable.

Potential to Extend: Too early to say.

Reports to: Head of QCAT Multifunctional Lead