Biopharmaceutical Formulation Specialist

1 month ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

About Thermo Fisher Scientific

We are the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them.

Job Summary

We are seeking a Senior Formulation Technician to join our team based in Brisbane. As a key member of our manufacturing team, you will be responsible for the production of biopharmaceutical products in compliance with international quality requirements.

Key Responsibilities

  • Support the execution of DSP unit operations (chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration and drug substance final fill) with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
  • Identify and communicate practical problems to the responsible person, demonstrating a pro-active attitude and personal initiative.
  • Maintain production suite, supplies, equipment, logbooks, and data, as well as closing out batch record and material reconciliation in accordance with site SOPs and policies.
  • Perform equipment maintenance and testing related to technical skills of Bioprocess Scientist DSP, and support the implementation of new procedures and/or equipment in the OPS department.
  • Author and revise SOPs and logbooks, adhering to Patheon cGMP Quality Management System and the Patheon EH&S requirements.
  • Complete corrective and preventive actions, contribute in deviation investigations and support the timely closure of deviation reports and change controls.
  • Implement lean (OE) initiatives and continuous improvements, and contribute to the transfer and understanding of specific new technologies to DSP.
  • Connect with suppliers about technical issues.

Requirements

  • 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.
  • Ability to work unsupervised, with good communication, flexibility, reliability and assertiveness, and responsible and proactive.
  • Excellent interpersonal skills.

Benefits

  • A competitive salary and performance related bonus structure.
  • Access to Thermo Fisher's global University.
  • Exposure to market leading & innovative technologies.
  • Career development opportunities in a leading global organization.

We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. 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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