About the Role:
Reporting to the Director CMC Technical Operations, the company wishes to appoint a CMC Development Manager who will provide technical support and oversee development, technological transfer, manufacturing and supply activities with CDMOs, enabling preclinical and clinical development of PET radiopharmaceuticals.
Responsibilities:
* Responsible for the development and management of outsourced PET radiopharmaceutical CMC project activities at various stages of drug development. Delivering milestones within agreed time, resources, and cost.
* Play a key role in defining and driving the radiopharmaceutical CMC strategy in terms of partners, capabilities, and innovation for the projects.
* Management of third party CDMOs activities, partner network and innovation, ensuring the accuracy and reliability of the data generated.
* Working closely with and support the Company’s Quality Assurance team to ensure that third-party suppliers and manufacturers operate at an appropriate level to secure product quality and maintain compliance with GMP and GDP.
* Develop appropriate CMC project plans and integrate these with the overall project plan. Monitor plans, highlight any risks to key milestones and take appropriate steps to mitigate these.
* Provision of technical expertise and support and adequate scientific interpretation and guidance.
* Securing high quality deliverables in a timely manner; implementing internal and external regulatory guidance.
* Preparing and reviewing relevant CMC-documents such as reports, SOPs and eCTD modules.
* Monitor and highlight Intellectual Property opportunities, prepare Intellectual Property submissions.
* Comply with all aspects if the Company’s Quality System.
* Provide input to the Company financial forecasts and budget setting activities; monitor expenditure and highlight any unplanned over or under spends.
* Ensure all relevant project documentation is stored in an organised manner on the Company shared drive.
* Undertake Continuing Professional Development activities in order to remain an expert in areas of responsibilities.
* Fulfil pharmacovigilance expectations as defined by the Company policy. Other duties as determined by business needs.
Requirements:
* Experienced in the manufacturing and research and development of PET radiopharmaceuticals. Including but not limited to:
* Development and validation of radiolabeling methods and formulation, translation of methods to automated synthesis units or radiopharmacy preparations.
* Development of methods to analyse and purify radiolabeled compounds.
* Understanding of industry area including ICH, FDA and EMA guidance relevant to radiopharmaceuticals drug development;
* Track record with technology transfer, analytical and process development/validation with API and drug product.
* Experience with the selection, setting up and oversight of CDMOs, related to the manufacture, analysis and/or supply chain. Excellent oral & written communication skills. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations.