About the role
This is a hands-on role at the intersection of analytical science, quality and medical-device manufacturing. You'll take responsibility for the day-to-day running of the laboratory, with a strong focus on HPLC and analytical testing, while helping build robust laboratory systems as the company moves towards commercial manufacturing.
Key responsibilities
- Performing and overseeing HPLC testing
- Drug content, content uniformity and drug-release testing
- Managing real-time and accelerated stability studies
- Developing and validating analytical methods
- Reviewing chromatograms, calculations and laboratory data
- Managing laboratory equipment, calibration and qualification
- Leading investigations into OOS/OOT results and unexpected findings
- Maintaining laboratory SOPs, protocols and documentation
- Supporting ISO 13485, EU MDR and regulatory requirements
- Managing laboratory stock, consumables, reagents and ordering
About you
- A degree in analytical chemistry, pharmaceutical science, chemistry, biochemistry or a related discipline is required
- Strong hands-on HPLC experience
- Highly organised and scientifically rigorous
- Comfortable taking ownership of a laboratory
- Experience in pharmaceutical, medical-device, biotechnology or another regulated laboratory environment would be highly valued
- Experience with HPLC method development and validation would be a strong advantage
- Experience with stability programmes would be a strong advantage
- Experience with ISO 13485, GMP/GLP and regulatory documentation would be a strong advantage
About us
E-Leviate Pharma is a small, ambitious New Zealand medical-device company at an exciting stage of growth, focused on innovative devices, smarter delivery and better women's health.