Technical Specialist/Scientist

POSITION SUMMARY

The Technical Specialist is part of the GMT (Global Manufacturing Technology) team and serves as technical expert for GMS (Global Manufacturing & Supply) and QC (Quality Control). The Technical Specialist is responsible for supporting GMS and QC by facilitating process improvements, new process and assay introductions and transfers from VMRD (Zoetis R&D) departments. They may additionally support process and equipment validations at the Melbourne and Wellington manufacturing sites.

POSITION RESPONSIBILITIES

Troubleshooting and continuous improvement:

• Provide scientific support and technical assistance for Quality Control (QC), Manufacturing (GMS) and Quality Assurance (QA)
• Conduct Analytical and Process Trend Analysis
• Identify and implement analytical improvements to improve assay robustness and meet regulatory requirements

· Identify and implement process optimisation opportunities to enhance yield, reduce variability, and improve overall manufacturing processes

· Lead root cause analysis for process or analytical deviations and inefficiencies

• Evaluate QC or production documentation and update as appropriate

· Author and/or review risk assessments, change controls, and deviation investigations related to analytical or production processes

• Participate in projects as directed by the GMT (Global Manufacturing Technology) Technical Manager

Assay validation, analytical method transfer and analytical support:

· Support QC with the execution of assay validation studies and provide analytical, procedural and instrument knowledge support, and where required, training and coaching.

• Creation, qualification and restandardisation of standards, controls and seeds.

· Preparation of protocols and reports.

Transition Away from Animal Testing (TAFAT):

· Develop new assays to support the exit of animal testing

· Transfer new assays to QC department

· Assist Regulatory and QA colleagues with the filing of new assays

Process Transfer and Improvement Activities:

• Support validation and equipment qualification activities
• Collaborate with cross-functional teams to ensure data integrity and compliance
• Liaise with production, quality, VMRD, and/or regulatory on implementation of new processes
• Prepare and execute technical trials to support technical transfers
• Build GMP documentation for technical transfers, including technical protocols, SOPs, quality standards, batch records and validation protocols/reports
• Participate in cell culture and bacterial fermentation projects as directed by the Technical Manager

ORGANISATIONAL RELATIONSHIPS

The incumbent will work closely with, Global Manufacturing and Technology (GMT), VMRD (Zoetis R&D), Site Quality, Production, Engineering and EHS colleagues, regulatory and third-party QC staff.

EDUCATION AND EXPERIENCE

· Minimum of a Bachelor’s degree in an applicable science or engineering field

· Minimum of 3 to 5 years’ experience working in a laboratory or pharmaceutical setting

· Desirable to have an Honours or Master’s Degree/PhD

TECHNICAL SKILLS REQUIREMENTS

· An understanding of GMP as well as corporate and regulatory quality standards

· An understanding of 6 sigma, Quality by Design, etc.

· A proven ability to analyse, assess and make recommendations on a given technical issue

· A knowledge of OGTR (Office of the Gene Technology Regulator) and Department of Agriculture requirement for working and handling GMOs and Quarantine Restricted Biologicals.

· Working knowledge in the analysis of proteins, viruses and bacteria using tools such as ELISA, Cell culture assays, virus infectivity assays.

· A demonstrated ability to work effectively and credibly with a range of different people

· A knowledge of microbiology gained through completion of a relevant science degree, further degree such Honours/Masters in a relevant field and/or direct research experience in a pharmaceutical company is an advantage

· A keen proactive and persistent desire to champion innovation and improvement for the site

· Computer literacy in word processing, spreadsheet analysis, presentation software and database software

· Experience in assay validation and analytical method transfers is beneficial

· Experience in manufacturing process transfers is beneficial