Title: Scientist - Bioanalytical and Molecular Assays
Location: Didcot, Oxfordshire, GBR, OX11 ORL
Duration: 18 months
Job Description:
The Role
* Client is seeking an experienced individual to join the Bioanalytical and Molecular Assays team to support regulated clinical studies and trials.
* A successful incumbent would help integrate regulated bioanalysis and basic science research, to move programs into the clinic as well as reverse-engineer clinical findings to novel opportunities for Client's pipeline.
Here's What You’ll Do
* Responsible for the design and execution of phase-appropriate bioanalytical strategies including quantitation of therapeutic proteins, immunogenicity (anti- drug antibodies and neutralizing antibody assays) and PK/PD assay method development, validation and sample testing under GLP.
* Responsible to ensure assays are developed in a timely manner to meet program timelines.
* Responsible to ensure the qualification or validation of assays is fit for purpose and meets regulatory standards and troubleshoot any issues that arise internally or with external CRO partners.
* Responsible for the development of various assays using ELISA, MSD, multiplex LBAs, immunoblotting and other relevant technologies
* Support establishing internal bioanalytical capability and facilitate method development to support Client's portfolio.
* Responsibilities also include analytical equipment qualifications, preparation and maintenance of SOP’s, determination and control of critical reagents.
* Collaborate with operations and sample management to define sample journey.
1. Here’s What You’ll Need (Basic Qualifications)
* A Ph.D. in Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 5 years of industry biotech/pharmaceutical experience.
* M.Sc. with extensive bioanalytical experience are considered.
* Experience with RNA, biologics and cell therapy preferred
* Knowledge of GLP and GCP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.
* Expert knowledge of various ligand binding assay platforms such as ECL, cell based assays and other methodologies for clinical assays is preferred
* Previous work experience in a CRO or bioanalytical lab within a regulated environment is an advantage
* Expert knowledge of Watson LIMS
* Attention to detail and ability to handle multiple projects in a fast-paced environment
* Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment.
* Experience with Lab Information Management Systems (LIMS) and electronic lab books (eLNB), would be an advantage.