Principal Study Director - Immunoassay
- Experience Level
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 Principal Study Director 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:
- Line Management responsibilities for Study Directors and/or Support Staff. Includes the following tasks:
- Oversight, training, mentoring, human resources and performance management of Study Directors and/or Support Staff as assigned.
- Ensure the scientific and regulatory outputs of Study Directors and/or Support Staff by ensuring compliance with internal procedures and processes and applicable regulations.
- Responsibility for monitoring the established Key Performance Indicators for Study Directors and/or Support Staff.
- Ensure Study Director resources, processes and priorities are in place to deliver client projects.
- Update and review of Analytical Laboratory Methods (ALM)
- Perform the role of Study Director autonomously for assigned studies ensuring timelines are met and scientific integrity and regulatory compliance of study data by the review of all runs. Troubleshoot scientific issues and coordinating with operations and, in particular, the Lead Analysts to ensure operational progression of studies.
To be successful in this role, you must have:
- Ordinary degree in the appropriate discipline.
- Minimum 8 years experience in regulated Bio-analysis, ideally in a pharmaceutical or CRO environment.
- Minimum of 5 years experience as a Study Director in a regulated environment.
- Demonstrated experience in communicating with clients on high level science issues.
- Demonstrated efficient problem solving and scientific data interpretation abilities.
- Demonstrated ability to effectively prioritize tasks under high pressure situations.
- Solid experience with Laboratory Information Management Systems (LIMS), preferably Watson.
- Solid experience with IA development.
- Demonstrated ability in scientific leadership.
- 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.
- Excellent written and verbal communication skills with the ability to write policies, SOPs, reports, methods and presentations.
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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