Verified Job
IT / Software / Data Analyst
Expression of Interest Study Director Immunobiology
IT / Software / Data Analyst
#419852
Remote / WFH
Job Description
Agilex Biolabs is Australia’s largest and most technologically advanced regulated bioanalytical and toxicology laboratory offering both large and small molecule drug development support with the recent expansion into the cell & gene therapy space. For over 25 years, we are recognised for our scale and proven track record for fast start up and reliable data.
The company offers the latest state-of-the-art bioanalytical equipment allowing us to serve clients with many different drug types and modalities in development. Our FDA-inspected bioanalytical facilities have OECD good laboratory practices (GLP) recognition with NATA and ISO 17025 accreditation, ensuring our clients have the utmost confidence in the integrity of our methods and results and in our ability to meet regulatory expectations. We also offer toxicology studies to support non-clinical programs through our established GLP facility in Brisbane.
As a global leader in providing flexible solutions, Agilex Biolabs has accelerated numerous biopharmaceutical and pharmaceutical drug development programs for clients in the APAC region, USA, and Europe.
Expressions of Interest
The Study Director – Immunobiology (IB) is responsible for performing Study Director functions for immunoassay and immunobiology based validations and analysis. This includes:
Manage studies to ensure timelines are firstly set appropriately taking into account, company and external stakeholder requirements, and once set, ensure timelines are achieved.
Communicate effectively with external stakeholders (i.e. clients, Clinical Research Organisations (CROs)).
Communicate with internal stakeholders (i.e. operations, Quality Assurance (QA), management) to ensure project progression.
Ensure the scientific integrity and regulatory compliance of study data by (at minimum) the review of all runs.
Troubleshoot scientific issues by liaising with appropriate groups including Research & Development (R&D), operations, management.
Coordinate with operations and, in particular, the Lead Analyst to ensure operational progression of studies.
Liaise with R&D to ensure smooth transition of methods into validation.
About you
You will have a relevant degree in life sciences and minimum 3 years’ experience in bio-analysis ideally in a pharmaceutical or CRO environment. You will have demonstrated experience in communciaing with clients on high science issues and have highly developed problem solving and scientific data interpretation skills. You will have a scientific background and understanding of Flow Cytometry and PCR. You will be a team player and have the ability to deliver tasks on time and with a high degree of accuracy.
Why Agilex Biolabs
As the leading bioanalytical laboratory for clinical trials, Agilex Biolabs is known globally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world. We recognise that our people are our most valuable asset. It is through our employees’ integrity, expertise, and hard work that we can provide high-quality bioanalytical services.
We provide a warm and welcoming work environment for all our employees, we believe that it is critical to the achievement of our organisational objectives that we encourage and maintain a culture which respects, values, and celebrates the wonderful diversity of our people. We promote a collaborative, and fun team environment where you will experience:
Honest and open communication
Collaborative teamwork
Supportive and caring environment
Mutual respect
Training & development opportunities
Flexibility and work-life balance
A culture which respects and values it's employees
How to apply
To join our team, please submit your CV along with a cover letter outlining your skills and experience - please submit as one word or PDF document. Please note due to the high volume of applications we receive, we will only contact you directly should you be successful in being shortlisted for the next stage of our recruitment process.
We may keep your resume on file for future employment opportunities, as advertised on Seek, however recommend that you continue to look for our future job advertisements and encourage you to apply to those you feel you are suited to. If you do not wish your details to be held for future opportunities, please contact us directly to have this removed.
The company offers the latest state-of-the-art bioanalytical equipment allowing us to serve clients with many different drug types and modalities in development. Our FDA-inspected bioanalytical facilities have OECD good laboratory practices (GLP) recognition with NATA and ISO 17025 accreditation, ensuring our clients have the utmost confidence in the integrity of our methods and results and in our ability to meet regulatory expectations. We also offer toxicology studies to support non-clinical programs through our established GLP facility in Brisbane.
As a global leader in providing flexible solutions, Agilex Biolabs has accelerated numerous biopharmaceutical and pharmaceutical drug development programs for clients in the APAC region, USA, and Europe.
Expressions of Interest
The Study Director – Immunobiology (IB) is responsible for performing Study Director functions for immunoassay and immunobiology based validations and analysis. This includes:
Manage studies to ensure timelines are firstly set appropriately taking into account, company and external stakeholder requirements, and once set, ensure timelines are achieved.
Communicate effectively with external stakeholders (i.e. clients, Clinical Research Organisations (CROs)).
Communicate with internal stakeholders (i.e. operations, Quality Assurance (QA), management) to ensure project progression.
Ensure the scientific integrity and regulatory compliance of study data by (at minimum) the review of all runs.
Troubleshoot scientific issues by liaising with appropriate groups including Research & Development (R&D), operations, management.
Coordinate with operations and, in particular, the Lead Analyst to ensure operational progression of studies.
Liaise with R&D to ensure smooth transition of methods into validation.
About you
You will have a relevant degree in life sciences and minimum 3 years’ experience in bio-analysis ideally in a pharmaceutical or CRO environment. You will have demonstrated experience in communciaing with clients on high science issues and have highly developed problem solving and scientific data interpretation skills. You will have a scientific background and understanding of Flow Cytometry and PCR. You will be a team player and have the ability to deliver tasks on time and with a high degree of accuracy.
Why Agilex Biolabs
As the leading bioanalytical laboratory for clinical trials, Agilex Biolabs is known globally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world. We recognise that our people are our most valuable asset. It is through our employees’ integrity, expertise, and hard work that we can provide high-quality bioanalytical services.
We provide a warm and welcoming work environment for all our employees, we believe that it is critical to the achievement of our organisational objectives that we encourage and maintain a culture which respects, values, and celebrates the wonderful diversity of our people. We promote a collaborative, and fun team environment where you will experience:
Honest and open communication
Collaborative teamwork
Supportive and caring environment
Mutual respect
Training & development opportunities
Flexibility and work-life balance
A culture which respects and values it's employees
How to apply
To join our team, please submit your CV along with a cover letter outlining your skills and experience - please submit as one word or PDF document. Please note due to the high volume of applications we receive, we will only contact you directly should you be successful in being shortlisted for the next stage of our recruitment process.
We may keep your resume on file for future employment opportunities, as advertised on Seek, however recommend that you continue to look for our future job advertisements and encourage you to apply to those you feel you are suited to. If you do not wish your details to be held for future opportunities, please contact us directly to have this removed.
