CMC Project Manager

CMC Project ManagerThe company is looking for a CMC Development Manager to support the development, manufacturing, and supply of radiopharma products. This role involves managing partnerships with Contract Development and Manufacturing Organizations (CDMOs) to advance the preclinical and clinical stages of drug development.Key Responsibilities:Project Management: Oversee and manage outsourced CMC projects for radiopharmaceuticals, ensuring they meet deadlines, budgets, and quality standards.Strategy and Planning: Help shape the strategy for radiopharmaceutical development, focusing on selecting the right partners and driving innovation.Partner Management: Manage third-party CDMO activities, ensuring reliable data and adherence to quality standards.Quality Assurance: Work closely with the Quality Assurance team to ensure all third-party suppliers and manufacturers comply with GMP and GDP standards.Technical Support: Provide technical expertise and guidance throughout the project, ensuring compliance with regulatory requirements.Documentation: Prepare and review key documents like reports, SOPs, and regulatory submissions.Budgeting: Assist with financial planning and monitor project spending.Continual Learning: Engage in ongoing professional development to stay current in the field.Requirements:Experience: Strong background in developing, manufacturing, and managing radiopharmaceuticals, including radio-labeling and method development.Regulatory Knowledge: Familiarity with ICH, FDA, and EMA guidelines related to radiopharmaceuticals.Partner Management: Experience in selecting and managing CDMOs for manufacturing and supply chain operations.Communication: Strong communication and organizational skills, with the ability to work effectively in global, cross-functional teams.Email applicants please forward to: [email protected]