As an Assay Development Scientist at Labcorp Drug Development Laboratories, you’ll play a pivotal role in channelling your scientific capabilities to make a positive impact on changing patients’ lives. At Labcorp Drug Development you will be focused on scientific advances in the analytical testing of biological therapeutics and emerging gene and cell therapies.
The Assay Development team, part of the R&D function within the Biopharmaceutical CMC Solutions, is responsible for the development and optimisation of cell-based potency assays to support projects in all phases of the drug development pipeline.
This is an exciting opportunity for you to join the group as a lab-based scientist, primarily based at the York facility, establishing and developing mode of action relevant cell-based potency assays in support of drug development projects.
Main Duties and Responsibilities:
* To be a lab-based scientist, delivering expertise in the area of cellular potency assay development and optimisation for the purpose of implementation in the quality control of drug development projects.
* To implement new technologies and current scientific thinking in the field of cellular potency assay development while working in partnership with colleagues in the assay development team to ensure that assays are robust and fit for purpose.
* To implement projects to agreed timelines such that the objectives of the project are met, including delivery of more than one agreed area of work in parallel where appropriate.
* To be an effective member of the Assay Development Team, contributing novel ideas and using judgement and knowledge where appropriate to influence the work of the project.
* To maintain an awareness of current developments in the literature, regulations and scientific community.
* To achieve personal scientific visibility through project contributions and internal presentations at departmental or functional meetings.
* Maintain accurate and reliable record keeping and to have a meticulous approach to the analysis and interpretation of assay data.
* Training of individuals in correct cellular potency assay execution.
* Act as the subject matter expert during troubleshooting and Analytical Investigation scenarios both with internal colleagues and external clients.
* Contribute to the continuous improvement process by identifying opportunities in the workplace where improvements can be made.
Essential Requirements:
* A BSc degree in a relevant scientific discipline (e.g. Biochemistry, Biomedical Sciences, Biology) plus relevant postgraduate experience in cellular potency assay design and development, achieved in the pharmaceutical or biotechnology industry or as part of an MSc or PhD program.
* Extensive experience in the handling and maintenance of mammalian cell cultures.
* Experience in 96-well plate cell-based bioassays (e.g. cytotoxicity, proliferation, ADCC), ELISA or AlphaLisa.
* A practical understanding of a wide range of cellular assay methods and technologies (for example fluorescence, luminescence, flow cytometry, TRF) as applied to a range of biological drug targets.
* Knowledge of GMP regulatory requirements relating to analytical testing and data integrity.
* Excellent problem-solving skills, strong delivery focus and communication skills.
* Be able to work both independently and within a project team.
Desirable Requirements:
* A PhD in a relevant scientific discipline.
* Experience in cell bank production.
* Experience in the automation of plate-based bioassays.
* Experience in the development of cellular assays for gene and cell therapy products.
* Knowledge and application of ‘design of experiment’ in assay design and development.
* Experience in the use of bioanalytical software (e.g. SoftMax Pro, PLA, QuBAS etc.).
* Excellent team working and networking skills with experience of interacting effectively across different disciplines and expertise.
* Experience of working in external collaborations both in academia and pharmaceutical industry.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply.
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