Executive Director, Manufacturing Process Optimization

5 days ago

Brisbane, Queensland, Australia beBeeManufacturing Full time US$150,000 - US$167,000

As a seasoned manufacturing professional, you will play a key role in driving the success of our late clinical-stage biotechnology firm.

About the Role:
  • Develop and execute comprehensive drug product filling manufacturing programs, ensuring timely and cost-effective delivery of high-quality products.
  • Provide technical guidance and oversight to Contract Development and Manufacturing Organizations (CDMOs) for process technology transfer and optimization.
  • Support lot release activities by coordinating closure of deviations, CAPAs, and product complaints within designated timelines.

This is an exceptional opportunity to partner with cross-functional teams, leveraging your expertise in regulatory compliance and strategic planning to advance treatments for serious immunological diseases.

Key Responsibilities:
  • Develop and manage project plans in accordance with cGMP, ICH, and FDA regulations, ensuring seamless execution of manufacturing operations.
  • Collaborate closely with stakeholders, including Drug Substance, Analytical Sciences, Quality Assurance, Supply Chain, Regulatory Affairs, Finance, and Program Management, to drive operational excellence.
  • Write and review relevant sections for regulatory submissions, including Annual Progress Reports (APRs) and Product Quality Review (PQRs).

We are committed to advancing innovative treatments that target the source of immunologic diseases, changing the standard of care for patients. Join us in this mission and contribute your expertise to make a meaningful impact.

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