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DSP Bioprocess Scientist

Thermo Fisher Scientific -
Brisbane QLD

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Job Details

Full-time
11 days ago

Full Job Description

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At Thermo Fisher Scientific, each one of our 150,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

Job Title

DSP Bioprocess Scientist

Reports to

DSP Team Leader

Group / Division

Pharma Service Group (PSG)

Career Band

Band 3

Job Family

Manufacturing - Formulation (MFGF)

Job Sub Family

Senior Formulation Technician

Job Code

OPS.MFGF.A03

Job Track

Associate

Position Location

Brisbane, Australia

Number of Direct Reports

Position Summary:

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

Key Responsibilities:

Tasks

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:

Qualifications & Experience

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.

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