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Senior Scientist
Bioassay Validation

About us

Everyone should have access to innovative therapies that represent the promise of lasting cures. At Theolytics we are working to transform patients’ lives, through world-leading science, with a great team. Our discovery platforms harness the power of viruses to systematically identify therapies optimised for a chosen patient population, with a focus on oncology (www.theolytics.com).

 

Theolytics is committed to creating, inspiring and protecting a culture of inclusivity and diversity in everything we do. We bring our authentic selves to work, and strive to find and support the best person for any given role within our team. Our recruitment leads with capability, values and performance.

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Opportunity

We are looking for a Bioassay Validation Specialist / Bioassay Validation Senior Scientist, with a good understanding of GCLP requirements, to join our team.

 

This position represents an excellent opportunity for someone looking to take responsibility in a fast-paced environment, working within an interdisciplinary team to develop new cancer treatments.

 

The role will include ensuring successful conduct of development, qualification and validation of bioassays for clinical sample analysis and management under GCLP; and, to ensure planning, execution, and data delivery of biomarker lab data for clinical trials.

Key responsibilities

 

Successful conduct of bioassay development and validation to appropriate GCLP standards. Oversight, management and performance of sample processing and analysis. Timely delivery of biomarker lab data for clinical trials that meet required regulatory and quality standards.

This role will involve

  • Ensure that the development, qualification, validation of bioassays and clinical samples meet regulatory and quality standards such as Good Clinical Laboratory Practice (GCLP). 

  • Sample analysis management ensuring timely delivery of biomarker lab data for clinical trial decision taking. 

  • Ownership of quality records (Deviations, Change Controls and CAPAs).

  • Work closely with clinical operations teams to coordinate and integrate clinical sample management, handling, storage, shipment and data transfer agreements. Monitor and track data generated during clinical execution.

  • Work closely with clinical operations teams to coordinate and integrate bioassays into clinical trial sample manuals.

  • Provide guidance to lab scientists to ensure: 

  • Accurate record keeping

  • Report writing that is concise, consistent, and of the required standard 

  • Assay qualification or validation to meet the requirements of authorities alongside proposed clinical trials 

  • Act as independent scientist reviewer and sign off lab books, verify the calculations, set locked electronic templates and approve technical SOPs. 

  • Perform bioassay development and validation experiments, and patient sample analysis. 

  • Provide operational input into study related documentation and processes, and ensure collection, delivery and analysis of bio-samples in compliance with GCLP.

  • Provide support with CRO management when required.

We’re looking for someone that has

Essential

  • Masters with experience in clinical bioassay validation, analysis, and clinical sample management in the industry setting

  • Up-to date GCLP certifications. 

  • Technical expertise and hands on clinical sample management.

  • Technical expertise and hands-on experience in  bioassay development, qualification and validation requirements in a regulated environment (GCLP) in a CRO or Biotech setting.

  • Practical knowledge and implementation of ICH guidelines such as Q14 and Q2(R2). 

  • Experience as independent scientist reviewer of validation reports and assays; quality knowledge to review and sign off lab books, verify calculations, setting locked electronic templates and approving technical SOPs.


 

Desirable

  • Non-clinical drug development experience as independent scientist reviewer.

  • Knowledge and ability to provide expert scientific and technical advice to development project teams on the identification, evaluation, and delivery of clinical bioassay methodologies in early phase clinical trials in cancer.

  • Keep up to date with scientific and technical developments in translational/bioassay science acting on new guidelines and initiatives.

  • Experience with quality records (Deviations, Change Controls and CAPAs).

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