Reporting to the Director CMC Technical Operations, the company wishes to appoint a CMC Associate Director who will provide technical support and oversee development, technological transfer, manufacturing and supply activities with CDMOs, enabling for preclinical and clinical development of PET radiopharmaceuticals. This position requires broad-based expertise to help create and implement phase-appropriate solutions.
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.
* Oversee preparation of CMC documents for IND/IMPD or NDA/MAA submissions.
* Preparing and reviewing relevant CMC-documents such as reports and SOPs.
* Provision of technical expertise and support and adequate scientific interpretation and guidance.
* Management of third party CDMOs activities, partner network and innovation, ensuring the accuracy and reliability of the data generated.
* Play a key role in defining and driving the radiopharmaceutical CMC strategy in terms of partners, capabilities, and innovation for the projects.
* 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.
* Securing high quality deliverables in a timely manner; implementing internal and external regulatory guidance.
* Monitor and highlight Intellectual Property opportunities, prepare Intellectual Property submissions.
* 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.
* 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.
* Experienced in preparing IND/IMPD or NDA/MAA submissions
* Track record within a pharmaceutical CMC role, with a focus technology transfer, analytical and process development/validation with API and parenteral drug products.
* 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.