Study Director - Immunobiology
- Experience Level
- Experienced (non-manager)
Agilex Biolabs is a Regulated Bioanalytical laboratory which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.
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 are committed to providing a challenging and stimulating environment where what our people do matters.
Are you a highly experienced and driven Study Director / Scientific Project Manager with proven experience in developing and validating flow cytometry assays (immunophenotyping and receptor occupancy assays) and/or cell-based neutralising or mode of action assays in a regulatory environment? Would you like to work for a growing global company that prides itself on delivering quality results every time, for every project? Do you have experience working with clients managing assigned studies from start up to close out? If the answer is yes, then we would like to hear from you.
As the Study Director – Immunobiology, you will work closely with the research and development designing flow cytometry assays to support clinical studies. You will also be responsible for the validation and study sample analysis and study conduct within a regulated GLP environment
This is a permanent full-time position, based in Thebarton, Adelaide, South Australia.
The position offers a competitive salary, and for suitably qualified and experienced interstate candidates relocation assistance is on offer.
For suitably qualified and experienced overseas candidates, visa sponsorship support and relocation assistance is on offer for them and their family.
Study Director and or Principal Investigator with overarching responsibility for assigned studies autonomously for a large number of clients and studies. Responsibilities include:
- Manage studies to ensure timelines are firstly set appropriately in line with company and external stakeholder requirements ensuring timelines are achieved.
- Communicate effectively with external and internal stakeholders to ensure project progression.
- Ensure the scientific integrity and regulatory compliance of study data.
- Troubleshoot scientific issues by liaising with appropriate groups including Research & Development (R&D), operations, management.
- Coordinate with operations to ensure operational progression of studies.
- Liaise with R&D to ensure smooth transition of methods into validation.
- Update and review Analytical Laboratory Methods (ALM).
- Input to Standard Operating Procedures (SOPs) relevant to Study Director role.
- Able to be assigned Deputy Study Director duties as required.
To be successful in this role, you must have:
- Ordinary degree in life science
- Minimum 5 - 8 years’ experience in regulated Bio-analysis, ideally in a pharmaceutical or CRO environment
- Minimum of 2 - 5 years’ experience working as a Study Director in a regulated environment project managing studies
- Demonstrated experience in communicating with clients on high level science issues
- Demonstrate efficient problem solving and scientific data interpretation abilities
- Proven ability to review Analytical Laboratory Methods (ALMs)
- Proven ability to develop and review bioanalytical SOPs
- Solid experience with Laboratory Information Management Systems (LIMS), preferably Watson.
- Solid experience with immunoassay development
- Solid experience with flow cytometry assay development and validation
- Solid experience with cell-based assay development and validation
- Experience with mentoring Study Directors (desirable)
- Ability to work effectively both in isolation and as part of a team.
- Proven ability to deliver tasks on time with a high degree of accuracy
- Demonstrated initiative, trust and reliability and the ability to work unsupervised.
- Willingness to work in and be supportive of a positive and dynamic team culture.
- High level of written and verbal communication skills.
We offer training and career development opportunities to build the skills and progress the careers of our employees. Our Quality commitment extends to a quality culture for our employees. We want you to enjoy working here, and promote a collaborative, and fun team environment.
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