Senior Manager, CMC Radiopharmaceuticals
Job Locations: US-NJ-Paramus
Job ID: 2025-1895
Category: CMC
Type: Regular Full-Time
Overview
The Senior Manager, CMC, Radiopharmaceuticals (RPT) will work on CMC aspects for SK Life Science Inc.'s RPT drug candidates, including but not limited to Ac225, In-111, Ga, Lu, etc. The candidate must be technically proficient in radiopharmaceuticals, radiometal chemistry, and have radiopharmaceutical development analytical expertise, as well as experience in CMC writing.
Responsibilities
Selection of CDMO and establishing comprehensive technical processes for RPT drug candidates to facilitate transfer and management of manufacturing processes to CDMOs, including identification and implementation of manufacturing and quality control procedures, equipment, and facilities.Organize and manage technology transfer to CDMOs.Review manufacturing and analytical documents (batch records, CoA, specifications, protocols, reports) from CDMOs for technical and compliance accuracy.Guide and decide on the selection and qualification of raw materials, packaging components, shippers, ensuring conformity to regulatory requirements. Develop and maintain relationships with key suppliers and service providers.Ensure compliance with relevant regulations, standards, and guidelines related to quality, safety, and environmental impact for CDMOs, internal R&D, and projects.Co-write the CMC modules of dossiers in IND/IMPD/annual reports.Communicate effectively with stakeholders, including management, clients, and vendors.Stay updated on technological advancements and market developments in alpha radio ligand therapy development and advise top management.Qualifications
PharmD, PhD in Radiochemistry, Chemical Engineering, Radiopharmaceuticals, or related life sciences fields.At least 5 years of experience in radiopharmaceutical manufacturing and process development.Strong technical knowledge in formulation, radiolysis, process validation, synthesis module qualification, and analytical methods, with strategic thinking and effective communication skills.Familiarity with FDA, EMA regulations, standards, and guidelines concerning quality, safety, and environmental impact.Excellent understanding of regulatory requirements for drug development, including US and EU standards.Fluency in English, both written and verbal.#J-18808-Ljbffr