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Production & Quality Leader – Biologics Manufacturing




Clinical Research, Production, Regulatory, Regulatory Affairs, Technical


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Job ID:



Job Title:  Production & Quality Leader

Location: Sydney, Australia

Company: Biopharmaceutical Company

Job Description:

Our client, a leading biopharmaceutical company based in Sydney, is seeking a highly skilled Production & Quality Leader with a strong background in bioprocess development and commercial cGMP biologics production. This key leadership role focuses on production and quality management to ensure the company’s success in delivering high-quality biologics products to the market.


Production Management:

  • Lead and manage all critical production and technical functions.
  • Collaborate with internal and external partners to achieve key deliverables.
  • Oversee process and analytics technology transfers.
  • Provide technical support for cGMP operations.
  • Drive production process scale-up and process robustness enhancement.
  • Implement lean manufacturing principles (Six Sigma) for efficiency.
  • Develop strategies for facility upgrades and enhancements.
  • Identify and troubleshoot process deviations and implement corrective and preventive actions.
  • Lead and author investigation reports in collaboration with relevant stakeholders.
  • Lead process validation design and protocol preparation and review.
  • Ensure product (DS and DP) release and tech transfer reports.
  • Drive continuous improvement projects to enhance COGs reduction.

Quality Management:

  • Collaborate with internal and external customers to resolve cGMP issues effectively.
  • Manage discrepancy investigation and CAPAs.
  • Oversee change control and management.
  • Manage key process development reports.
  • Implement and manage a continuous improvement (CI) program.
  • Drive strong collaboration and communication across Quality teams.
  • Remain current on regulatory trends related to biologics manufacturing.

Leadership and Management:

  • Lead, direct, and manage a team in Production and Quality.
  • Manage budget, projects, personnel, and schedules.
  • Develop strategic objectives to align with the organisation’s goals.
  • Design the organisation and recruit key talents to strengthen capabilities.
  • Coach, mentor, and systematically develop key staff.
  • Build and establish appropriate processes and systems for efficiency.
  • Drive collaboration with other departments, including Regulatory and Product Development, Tech Transfer teams.
  • Lead new process internal tech transfers from Product Development.


  • Preference for Master or Ph.D. degree in relevant biological sciences and/or engineering. 
  • Minimum of 15 years of industry experience in pharmaceutical and/or biotechnology industries.
  • Proven leadership skills and track record of managing technical groups and teams.
  • Strong project team management skills.
  • Excellent verbal and written communication skills.
  • Demonstrated expertise in bioprocess development and cGMP biologics production.
  • Familiarity with regulatory issues in biologics manufacturing.
  • Creative problem-solving skills under resource constraints.
  • Appreciation of cGMP principles and practices.
  • Strong technical problem-solving abilities.
  • Proven success in working effectively in a team environment.
  • Ability to remain current on emerging technologies, scientific breakthroughs, and regulatory trends.

Our client is an equal opportunity employer and values diversity at their company. Please note only applicants who meet the above criteria will be contacted. This role is only open to those who have the right to work permanently and who have validated local experience in Australia. No Visa or Sponsorship offered. Fluent English language skills are expected.

For a confidential discussion contact Alicia Keenan on akeenan@aicila.com or apply online referencing VRN2637 outlining your suitability for the role

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