Hobson Prior are looking for a Bioanalytical Study Manager to join a top biopharmaceutical company who purely concentrate on neurology and immunology. This position will be on a contract basis located in Slough.

Job Responsibilities:

• You will interact with bioanalytical project representatives to execute the bioanalytical strategy for a large molecule program, including method transfer/validation and bioanalysis (PK, ADA and BM) at key strategic vendors.
• Oversee (neutralizing) immunogenicity method development and validation for different programs, at our key strategic vendors.
• Partake in harmonization of bioanalytical testing and reporting processes.
• Assures bioanalytical tasks are executed with good scientific quality, within the adequate quality system, and within the agreed upon timelines.
• Collaborate with multiple internal and external stakeholders to execute the bioanalytical strategy.
• Participate in clinical study design and documentation (lab manual, protocol, SAP,…).
• Partake in writing of the Immunogenicity Risk Assessment.

Requirements:

• Prior experience in the pharma or CRO industry supporting regulatory bioanalysis of large molecules.
• Knowledge of a range of bioanalytical techniques, mainly (neutralizing) immunogenicity assays and ligand binding assays. Knowledge of the Simoa platform is a plus.
• Experience with change management.
• Knowledge of the latest regulatory standards required for GXP studies including international guidance's published by regulatory agencies such as FDA, EMA.
• Knowledge of diagnostic assay set up and validation is a plus.
• Previous experience managing contract research organizations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.