- An environment which allows the individual to grow alongside the company.
- A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do.
- The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved.
- A multicultural environment where every voice is heard.
- Competitive remuneration package which includes an annual Bonus + Employee Share Options.
- Close to public transport.
-
Qc Method Development
1 week ago
Aegros Therapeutics Pty Ltd Macquarie Park, AustraliaAegros 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 therap ...
-
Learning & Development Team Leader - Global
1 week ago
Evans Petersen Healthcare Macquarie Park, Australia**The Company** · This global pharmaceutical company has long been improving the lives of humans across the globe and has a strong focus on achieving outstanding results for its well-established product range. They are renowned for their high-achieving culture and have a strong c ...
-
Principal Account Executive
1 week ago
DXC Technology Macquarie Park, Australia**Summary** · Manages client satisfaction and provides resources to larger accounts; ensures profit objectives are met, and manages ongoing strategic planning for a single complex account. Develops relationships with clients to create synergy between client needs and effective bu ...
-
Order 2 Cash Analyst
3 weeks ago
DXC Technology Macquarie Park, AustraliaDistributes invoices, posts batches, receives payments, processes accounts payable invoices, and mails accounts payable checks. · - Calculates moderately complex commissions, interest, and payments for each transaction; creates and distributes moderately complex commission statem ...
-
Customer Logistics Capability Lead
2 weeks ago
Brambles Group Macquarie Park, AustraliaCHEP helps move more goods to more people, in more places than any other organization on earth via our 300 million pallets, crates and containers. We employ 11,000 people and operate in more than 55 countries. Through our pioneering and sustainable share-and-reuse business model, ...
-
Bid/tender Manager
3 weeks ago
Eptec Macquarie Park, Australia**Company Overview**: · Eptec Group is a market leader in specialist maintenance services to both the Defence and Infrastructure industries. With over 20 years of experience, we deliver Asset Life Extension of complex operational assets through a range of solutions, Australia wid ...
-
Sales Representative
3 weeks ago
Wolters Kluwer Macquarie Park, AustraliaRole Summary · Develops an understanding of business, financials, products/services and the market within multiple job families under the Sales job family group. Plans, organizes, implements sales activities to achieve defined revenue goals. Maintains existing customer base. Deve ...
-
Clinical Marketing and Education Manager
3 weeks ago
Alcon Macquarie Park, AustraliaAre you an agile learner capable of absorbing clinical and technical information to deliver compelling and memorable content to a variety of audiences using different methods of engagement? · We are looking for a talented professional with a passion for working in a technical env ...
-
Customer Service Representative
2 weeks ago
Healthcare Professionals Group Macquarie Park, Australia**Benefits** · - Work for a growing Australian owned medical device logistics company · - Opportunities for growth and development · - Supportive and inclusive team culture · - Macquarie Park Location · - On site parking available, and right next to Metro station · - $60,000 - $6 ...
-
Test Lead
3 weeks ago
Catholic Healthcare Macquarie Park, Australia**Job Description**: · **Test Lead - Initial 18mth Contract** · - Based in Macquarie Park, short walk from Metro Station · - 7 Additional leave days per year + Salary Packaging + WFH options · - Join a leading not-for-profit provider of Aged Care Services - Growth Industry · - Co ...
-
Structural Drafter
2 weeks ago
Freyssinet Macquarie Park, Australia**General information**: · **Affiliated entity **:Freyssinet Australia and New Zealand is a multifaceted specialist contractor providing innovative solutions for remediation, post-tensioning, and specialist civil engineering. We have an unrivalled reputation in specialised civil ...
-
Head of Development
1 week ago
Aegros Therapeutics Pty Ltd Macquarie Park, Australia**About Aegros** · 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 ...
-
Model Assurance Analyst
3 weeks ago
Transport For NSW Macquarie Park, Australia Full time**Model assurance analyst (Temporary full time until September 2024)**: · - Organisation/Entity: Transport For NSW- Job category: Projects- Job location: Macquarie Park, NSW, AU, 2113- Job reference number: Employment type: Fixed Term Full-Time- Salary range: $ $ **You can be par ...
-
Test Lead
1 week ago
Catholic Healthcare Macquarie Park, Australia**Job Description**: · **Test Lead - Initial 18mth Contract** · - Based in Macquarie Park, short walk from Metro Station · - 7 Additional leave days per year + Salary Packaging + WFH options · - Join a leading not-for-profit provider of Aged Care Services · - Growth Industry & ou ...
-
Project Finance Analyst
2 weeks ago
Sustainability Consulting Macquarie Park, AustraliaAre you Studying CPA or CA? · - Do you desire working around qualified accountants? · - Do you want to work for a global organization? · Role: Project Finance Analyst · Company: Global Energy Management organization · Contract: Day rate contract (Temp to Perm) · Duration: Initial ...
-
Production Manager
2 weeks ago
Aegros Therapeutics Pty Ltd Macquarie Park, AustraliaAegros 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 therap ...
-
Learning & Development Manager
2 weeks ago
AstraZeneca Macquarie Park, Australia**Learning & Development Manager** · We are looking for an experienced & agile Learning & Development Manager to lead our L&D Team: · - An exciting 12-month Full-time opportunity · - Work in a manner which protects the safety and well-being of self, others and the environment · * ...
-
Head of Finance
3 weeks ago
AstraZeneca Macquarie Park, Australia**About AstraZeneca** · At AstraZeneca, We are proud of our state-of-the-art manufacturing plant and head office located in Macquarie Park. The site has demonstrated outstanding supply performance and delivery. It is globally regarded as one of the most cost efficient and success ...
-
Customer Experience
3 weeks ago
Optus Macquarie Park, Australia**Customer Experience (CX) Optimisation Manager**: · **Date**:31 Jul 2023 · **Location**: Macquarie Park, Australia · **Company**:Singtel Group · At Optus, we don't sit back and let the future happen to us - we're out there making it. By expanding into new technology and relentle ...
-
NextSense Macquarie Park, AustraliaPosted: 28/11/2023 · Closing Date: 15/12/2023 · Job Type: Permanent - Full Time · Location: Macquarie · Job Category: Education · **Our Purpose and Ambition** · NextSense is a not-for-profit organisation supporting people with vision or hearing loss across Australia. We work with ...
QC Method Development - Macquarie Park, Australia - Aegros Therapeutics Pty Ltd
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 HaemaFracTM 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 arisen for 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 R&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...
Interested? Apply today...
Please note the successful candidate must complete a pre-employment medical assessment and undergo background history checks for any items which may be relevant to the duties of the role.
Applicants must be authorised to work in Australia.
