- Experience Level
- Experienced (non-manager)
- Australian based
Our client is a Regulated Bioanalytical Laboratory which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry internationally. They are a fast-growing global company that prides itself on delivering quality results, every time, for every project.
You will be a highly experienced and driven Study Director / Scientific Project Manager with LCMS experience. Experienced working with clients, you will have overarching responsibility for assigned studies, managing the studies from start up to close out. In addition, you will;
- Perform the role of Study Director and/or Principal Investigator managing studies to ensure timelines are firstly set appropriately, considering company and external stakeholder requirements, and once set, ensure timelines are achieved.
- Communicate effectively with external stakeholders.
- Communicate with internal stakeholders to ensure project progression.
- Ensure the scientific integrity and regulatory compliance of study data by the review of all information.
- Troubleshoot scientific issues by liaising with appropriate groups including Research & Development, Operations and Management.
- Update and review Analytical Laboratory Methods (ALM).
- Provide input to Standard Operating Procedures (SOPs).
- Coordinate with Operations and the Lead Analyst to ensure operational progression of studies.
- Liaise with R&D to ensure smooth transition of methods into validation.
- Minimum of a Degree in life sciences/analytical sciences/drug development/pharmaceutical sciences.
- Minimum 3 years' experience in regulated Bio-analysis, in pharmaceutical company/biotech or CRO.
- Minimum of 1 years' experience as a Study Director in a Clinical Research Organisation.
- Demonstrated experience in communicating with clients on high level science issues.
- 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.
- Experience with Laboratory Information Management Systems (LIMS), preferably Watson
- Experience with LCMS development
This is a permanent full-time position based in Australia. For suitably qualified and experienced overseas candidates, visa sponsorship support and relocation assistance is on offer.
To join our client in this new and exciting opportunity, please email your cover letter & CV to firstname.lastname@example.org.
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