QC Method Development Validation Manager
Aegros Therapeutics Pty Ltd, Australia
Job Description
Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.
At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.
Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collected into life saving hyperimmune products.
It's no secret that Aegros is expanding rapidly! An exciting opportunity has arisenfor a QC Method Development and Validation Manager to join our team. Reporting to the Head of QCU, you will be responsible for developing and validating analytical methods to support process development, as well as performing routine complex analytical testing of samples.
In this role you will be instrumental in collaborating with cross-functional teams to ensure that all methods meet project timelines and are in compliance with all required regulatory guidelines and standards.
The role will require to manage a team of analysts performing method validation and development.
What you will be involved in
• Lead the team of analysts performing method validation and development activities.
• Ensure training and development needs are appropriately identified and the necessary training and support for team members are facilitated so they are properly trained at all times to comply with training requirements of the company and Quality System.
• Mentor/guide Quality Control analysts on daily laboratory work, experimental design, data interpretation, and troubleshooting, as well as train new group members on analytical lab skills.
• Oversees and coordinates aspects of product and analytical method development.
• Develop analytical methods, suitable for progressive stages of pharmaceutical development and/or supervise activities.
• Ensure that all work is in compliance with applicable regulations and SOPs for the development work and the conducted experiments.
• Point of contact with contract laboratories and vendors for specific projects regarding, technical transfers, investigations, and development.
• Performs overall review of data generated on development and clinical supply samples.
• Develops, reviews, and approves source documents for regulatory submissions.
• Authors, reviews, and approves SOPs, analytical methods, stability and method validation protocols and reports.
• Assist in bringing new technology and equipment into the QC lab and their subsequent qualification.
• Present to cross functional teams and effectively communicate critical analytical issues and solution.
• Plans and executes assigned experiments that support non-routine development activities and project goals.
• Selects appropriate methods and techniques to support the programs.
• Troubleshoots analytical methods and lab instrumentations.
• Recommends alternatives, research new methods and techniques.
• Ability to evaluate quality of data and to process and interpret data.
• Subject matter expertise in an analytical technique and acts as a resource for other employees within the department.
• Works cross-functionally with all RAQA department areas and Ramp;D teams.
• Authors reports, protocols, test methods, and other documentation as required.
• Perform any other legitimate duties as directed by the Head of QCU or their delegates.
• Practical application of the Quality System related to the Quality Control Department, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management.
• Undertake internal audits and participate in customer/regulatory audits as per the requirement.
Requirements
What we would expect from you:
• Supervisory experience in leading a team.
• Multi-disciplinary knowledge of Quality Control.
• Advanced capability for logical, analytical, and strategic thinking.
• Problem analysis and resolution skills required.
• Experience working in a laboratory under cGMP, ICH, USP, or global compendial regulations and guidance, particularly as related to analytical method development and validation.
• Highly effective and capable of presenting technical data to guide and influence.
• Scientific technical writing ability including authoring and revising SOPs or technical reports.
• Highly skilled at troubleshooting assay and equipment issues.
Benefits
Here’s what we can offer you
- An environment which allows the individual to grow alongside the company.
- A role that provides the bandwidth to explore innovative