Scientist - Bioanalytical & Molecular Assays

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.

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.