Study Director - Immunoassay
- 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 Immunoassay bioanalysis experience seeking a new opportunity? 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.
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.
Key responsibilities include:
- Management of studies to ensure timelines are set appropriately and subsequently met, taking into account company and external stakeholder requirements.
- Communicate effectively with clients to ensure they are kept up to date with the progress of their studies.
- Ensure the scientific integrity and regulatory compliance of study data by the review of all runs.
- Troubleshoot scientific issues by liaising with appropriate groups including Research & Development (R&D), operations, management.
- Coordinate with operations, in particular, the Lead Analyst to ensure operational progression of studies.
- Liaise with R&D to ensure smooth transition of methods into validation
- Communicate with internal stakeholders to ensure project progression.
- 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.
- 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 sciences.
- Minimum 5 years experience in regulated Bio-analysis, ideally in a pharmaceutical or CRO environment.
- Minimum of 2 years work experience as a Study Director.
- Demonstrated experience in communicating with clients on high level science issues.
- Experience with Laboratory Information Management Systems (LIMS), preferably Watson.
- Experience with immunoassay development.
- Proven ability to review SOPs and ALMs.
- Demonstrate efficient problem solving and scientific data interpretation abilities
- 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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