DSP Bioprocess Scientist Full-time

DSP Bioprocess Scientist

Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.

Key Responsibilities:

• Execute DSP unit operations including chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, and drug substance final fill in accordance with approved protocols
• Follow production schedules, batch records, and SOPs in a cleanroom cGMP environment
• Monitor processes and identify operational or technical issues during execution
• Escalate issues and communicate effectively with responsible personnel
• Maintain production suites, equipment, and supplies to ensure operational readiness
• Complete logbooks, batch documentation, and ensure accurate data recording
• Perform batch record review, closure, and material reconciliation
• Conduct routine equipment maintenance, calibration checks, and functional testing
• Troubleshoot equipment and process issues within scope of role
• Support implementation of new equipment and procedures within DSP operations
• Author, revise, and maintain SOPs, logbooks, and controlled documents
• Participate in deviation investigations and root cause analysis
• Complete corrective and preventive actions (CAPA) in a timely manner
• Support closure of deviations and change controls
• Participate in lean (Operational Excellence) initiatives and continuous improvement activities
• Assist in technology transfer activities and adoption of new DSP processes
• Communicate with suppliers/vendors to resolve technical issues

Responsibilities:

• Ensure compliant execution of DSP manufacturing activities under cGMP conditions
• Maintain high standards of data integrity, documentation accuracy, and traceability
• Take ownership of production area readiness including equipment, materials, and documentation
• Proactively identify, communicate, and help resolve operational issues
• Ensure equipment is maintained, functional, and fit for purpose
• Contribute to continuous improvement and operational efficiency initiatives
• Support implementation and understanding of new technologies within DSP
• Adhere to Thermo Fisher Scientific cGMP Quality Management System requirements
• Comply with Environmental Health & Safety (EH&S) policies and procedures
• Support quality systems including deviations, CAPA, and change control processes
• Maintain effective communication with internal stakeholders and external suppliers

Frequent Contacts:

• Internal: MSS, USP, OTR, ENG, VAL, MSAT, QA, QC, WHS and EH&S
• External: Client, auditor/regulator, vendor/supplier

Minimum Requirements/Qualifications:

• Either experience in pharmaceutical industry OR tertiary education in science or engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology).
• Good understanding of cGMP practices.

Skills & Attributes:

• Ability to work unsupervised.
• Good communication, flexibility, reliability and assertiveness.
• Responsible and proactive.

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment.
• Work safely and only perform tasks if currently proficient and / or authorised.
• Report hazardous conditions, hazardous actions, incidents and near-miss incidents.
• Participate in EH&S activities (such as inspections and risk assessments) as advised.
• Your position may require you to be on shift. Should this be a requirement of your position, you will be remunerated per the Company's policy.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.