My client is a leading Australian owned and rapidly growing full service CRO based in South Australia, they pride themselves on being the only Australian CRO to offer a full suite of in house services for conducting early-phase clinical trials with efficacy.
On offer for the right candidate is this newly created role and a very competitive salary and pension (In Australia known as: Supperanuation which is 9.5% of the base salary), Covered visa expenses + sponsorship, relocation assistance and compensation included too.
Role / Responsibilities:
Development, transfers and pre-validation of robust bioanalytical methods (mainly for New Biological Entities, Biosimilars, Anti Drug Antibodies, Neutralising Antibodies, and Biomarkers); that will meet the Bioanalytical Method Validation guidelines of the regulatory authorities (FDA, EMA) in a timely and cost-effective manner.
Lead troubleshooting and technical investigations for bioanalytical laboratory methods with support from the Research and Development Manager and/or senior staff members.
Assists Study Director and the bioanalytical laboratory team in method transfers as required.
Write and Review Analytical Laboratory Methods.
Timely and effective communication with clients and internal Bioanalytical Regulatory Group on project status in an environment with rapidly changing priorities.
Support Operational Management to implement training programs for new staff.
Contribute to internal strategic innovation meetings and initiatives.
Escalate troubleshooting and other issues with assays to the Research and Development Manager that lead to additional activity outside of scope of work or significant increase in timelines.
Perform scientific review of SOPs.
Support the Research and Development Manager by following processes for managing R&D projects and escalation of any resourcing concerns as required.
Support the bioanalytical laboratory team and Research and Development Manger by providing scientific input into assay development, troubleshooting and recent regulatory guidance.
Support review of new projects as required.
Adhere to OECD GLP regulations, guidelines and SOPs, as applicable.
Departmental and Organisational Responsibilities
Embrace the core values of the company and endeavor to display those attributes at all times with clients and staff alike.
Commit to our training programs to ensure we are at the forefront of technology in the Asia Pacific region
Commit to adhere to our quality systems.
Remain current with required reading of SOPs relevant to the role and applicable duties.
Other duties as directed by Line Management or delegate.
Take reasonable care for your own health and safety and that of other personnel who may be affected by their conduct. These include general staff responsibilities and those additional responsibilities that apply for Managers, Team Leaders and other Personnel.
Skills / Experience:
Minimum 4 years experience of working in an analytical laboratory (CRO experience highly desirable).
Minimum 2 years experience in analytical method development, specifically ligand binding assays.
High level of written and verbal communication skills.
Proven ability to deliver tasks on time and with a high degree of accuracy.
Demonstrate efficient problem solving and scientific data interpretation abilities.
Demonstrated experience in communicating with clients on high level science issues.
Proven ability to maintain strict adherence to client confidentiality issues.
Ability to multitasking
High attention to details.
Demonstrated initiative, trust and reliability and the ability to work largely unsupervised.
Experience gained in a regulated bioanalytical laboratory desired.
If you feel you have the right skills and experience for this position then please apply now, for further information please email: email@example.com