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Job description

We are excited to be partnering with a leading global pharmaceutical services company, who are looking for an experienced Manager to be the operational lead for the establishment of their large molecule bioanalysis function.

The role is a key hire for them as it will support all start-up priorities, putting in place the required systems and SOPs and validating them against different regulatory requirements, as well as recruitment and training of the large molecule analysis team.

The key responsibilities for the role are:

The day to day running of the area and accountability for the delivery of all large molecule bioanalytical studies, including method development & validation, sample analysis and equipment validation studies.
Lead on regulatory and non-regulatory validation and sample analysis studies, including equipment validation.
Conduct thorough analysis and validation of protocols, generating study reports and data transfer agreements. Ensuring all study data is reviewed for accuracy and GLP / GCP compliance.
Provide regulatory expertise for the interpretation and implementation of regulatory requirements relating to the bioanalysis of large molecules (PK, TK ADA and biomarkers).

The required experience for this role is:

A strong background in bioanalysis of large molecules. This includes all hands-on technical knowledge through to method development, validation and troubleshooting large molecule analytical techniques.
Established leadership experience, comfortable in a managing role and can effectively establish, grow and guide the new team.

Please send a copy of your CV to alexander.garrett@biotalent.com to apply!