Senior Scientist, CMC Analytical Development

Reporting:

Vice President, CMC

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, method validation, quality control and radiochemistry, with a focus on ensuring the safety, efficacy, and compliance of radiopharmaceutical products. This role involves method development, validation, and routine analysis of radiopharmaceuticals in accordance with regulatory guidelines.

Illustrative Breadth of 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.

Requirements/Skills:

·       Bachelor’s or Master’s degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, or a related field.

·       5 – 7+ years of hands-on experience in analytical chemistry, preferably in drug product development, radiopharmaceuticals or a regulated environment.

·       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.

·       Demonstrated experience in drafting method protocol, execution and final report drafting to approval.

·       Excellent problem-solving skills and attention to detail.

·       Strong written and verbal communication skills.

·       Ability to work independently and as part of a team in a fast-paced environment.

Mariana Oncology’s Principles

·      Building a Legacy

·      Execution Excellence

·      Courage of our Convictions