AssureBio have exclusively partnered with an exciting Biopharmaceutical organisation who are looking to recruit a Head of Analytical Development.
Key Responsibilities
Provide world class technical leadership for the analytical development function.
Set up and execute analytical strategy in partnership with QC to support drug product registration, clinical release and commercialisation.
Develop an analytical development plan identifying the required strategy, resources and tools required to succeed.
Deliver next generation methods to support improved biosafety, process characterisation and control to enable efficiency and scientific decision making.
Provide technical expertise and demonstrate troubleshooting capabilities across a range of analytical techniques.
Ensure GMP compliance, adherence to internal procedures in all analytical operations, including determining when GMP standards are required and are not required.
Manage Development analytical timelines to ensure that all analytical deliverables are met
Provide technical review and approval of regulatory documentation.
Execute analytical method development activities of drug products based on QbD principles and regulatory requirements.
Establish in-house systems and procedures to ensure GLP practices and regulatory requirements for all analytical activity.
Responsible for trouble shooting related to testing methods, stability studies, test results and designing of additional experimentations as necessary, in support of QC.
Preparation and review of specifications, method of analysis procedures and analytical development reports, with QC, for newly developed of changed products.
Assisting and resolving technical queries raised during technology transfer activities and regulatory submissions.
Assessment and coordination on regulatory deficiencies, as related to analytical development or as directed.
Providing mentoring and coaching to those you work alongside or as directed.
