We have a really exciting opportunity for an experienced Senior Method Development Scientist (Immunoassay) at a leading clinical services company based in Australia. The main purpose of the role is to perform analytical method development and transfer for ligand-binding assays.
Key Responsibilities and Duties:
- Responsible for bioanalytical method development, transfer and pre-validation and ensure that Bioanalytical Method Validation guidelines (FDA, EMA) are met in a timely and cost-effective manner
- Lead troubleshooting and technical investigations with support from Manager and/or senior staff members
- Support and manage R&D projects and escalate any resourcing concerns, as well as review new projects as required
- Write and Review Analytical Laboratory Methods and Company SOPs; contribute to Continuous Improvement
- Ensure timely and effective communication with clients and internal Bioanalytical Regulatory Group on all projects in a rapidly changing environment
- Support Operational Management to implement training programs for new staff
- Ensure adherence to OECD GLP regulations as well as Company Guidelines, Quality Systems and SOPs
Ideal Skills and Qualifications:
- Minimum 4 years’ experience in a regulated analytical/bioanalytical laboratory (preferably CRO)
- Minimum 2 years’ experience in analytical method development (specifically ligand-binding assays)
- Degree qualified, or equivalent, in a relevant scientific discipline
- Proven experience delivering tasks on time to a high degree of accuracy
- Demonstrated ability to mentor, train and supervise
- Ability to analyse problems, formulate effective solutions and interpret scientific data
The company is a Contract Research Organisation specialising in providing drug development services for the pharmaceutical and biotechnology industries. You will be working in their state-of-the-art facilities based in Adelaide, Australia, with Visa and relocation support provided.
If you are interested or have any questions about this role, feel free to contact Harriet at CY Partners (0191 477 4733).
- Agency: CY Partners Recruitment
- Contact: Harriet Mak
- Phone: 0191 477 4733
- Reference: HMSrMDAu
- Posted: 9th January 2019
- Expires: 6th February 2019