Senior Scientist, CMC Analytical Development

Senior Scientist, CMC Analytical Development Join to apply for the Senior Scientist, CMC Analytical Development role at Mariana Oncology . Get AI-powered advice on this job and more exclusive features. Job Description We are seeking an experienced Senior Scientist, CMC Analytical Development to join Mariana’s CMC organization, advancing personalized medicine and radiopharmaceuticals. The ideal candidate will have a strong background in analytical chemistry, method development, validation, quality control, and radiochemistry, with a focus on ensuring the safety, efficacy, and compliance of radiopharmaceutical products. Responsibilities include method development, validation, and routine analysis of radiopharmaceuticals in accordance with regulatory guidelines. Reporting Line Vice President, CMC Responsibilities Perform analytical testing of radiopharmaceuticals using techniques such as HPLC, GC, TLC, ICP-MS, LC-MS, and gamma spectroscopy. Develop, validate, and optimize analytical methods for the characterization and quantification of radiopharmaceutical compounds. Conduct stability studies and ensure compliance with ICH, FDA, and EMA guidelines. Prepare and review technical documents, including SOPs, protocols, and reports. Collaborate with cross-functional teams to support product development, manufacturing, and quality assurance. Troubleshoot and maintain analytical instruments, ensuring accurate and reliable results. Ensure adherence to GMP, GLP, and radiation safety protocols. Stay current with industry trends, regulatory requirements, and advancements in analytical chemistry and radiopharmaceuticals. Qualifications and Skills Bachelor’s or Master’s degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, or related field. 5–7+ years of hands-on experience in analytical chemistry, preferably in drug development, radiopharmaceuticals, or regulated environments. Proficiency in analytical techniques such as HPLC, GC, TLC, ICP-MS, LC-MS, and gamma spectroscopy. Strong understanding of GMP, GLP, and regulatory requirements for radiopharmaceuticals. Experience with method development, validation, and transfer. Experience in drafting method protocols, execution, and final report drafting for approval. Excellent problem-solving skills and attention to detail. Strong written and verbal communication skills. Ability to work independently and collaboratively in a fast-paced environment. Company Principles Building a Legacy Execution Excellence Courage of our Convictions Additional Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analysis, and Information Technology #J-18808-Ljbffr Mariana Oncology