Scientist, Analytical Development

Mariana Oncology•Watertown, MA

1d•$93,800 - $174,200

About The Position

We are seeking an experienced Scientist I, CMC Analytical Development to join Mariana’s CMC organization and contribute to the development of innovative radiopharmaceuticals and personalized medicine. The ideal candidate will have a strong background in analytical chemistry, analytical method development, method transfer, quality control, and radiochemistry, with a demonstrated commitment to ensuring the quality, safety, efficacy, and regulatory compliance of radiopharmaceutical products. This role will be responsible for supporting the development, optimization, qualification, transfer, and routine application of analytical methods for radiopharmaceuticals within CMC organization. The successful candidate will work cross-functionally with CMC, process development, quality, and external partners to generate high-quality analytical data and support product development in accordance with applicable regulatory guidelines and industry standards.

Requirements

PhD degree in Analytical Chemistry, Radiochemistry, Pharmaceutical Sciences, or a related field with 0+ years experience in CMC analytical development, radiopharmaceuticals or a regulated environment; BS or MS degree with 4-6+ years of industry experience.
Experience with GMP, GLP, ICH guidelines and applicable regulatory requirements.
Proficiency in analytical techniques such as HPLC, iTLC, and related analytical technologies required.
Strong problem solving and troubleshooting skills, with a high level of attention to detail and commitment to generating accurate, reliable, and reproducible analytical results.
Ability to work independently while collaborating effectively with cross-functional teams in a fast-paced environment.
Strong communication and teamwork skills, with the ability to effectively communicate analytical results, technical issues.

Nice To Haves

Experience working with radiopharmaceuticals is preferred; experience with non-radioactive compounds in analytical development is also highly valued.
Experience with ICP-MS, LC-MS, GC, and gamma spectroscopy preferred.
Knowledge or experience with mass spectrometry for compound characterization and impurity identification is a plus.
Familiarity with stability studies and stability-indicating methods, including evaluation of potential degradation pathways and degradation products is a plus.
Hands-on experience with analytical method development, optimization, qualification, and technology transfer strongly preferred.
Good understanding of the radiation safety regulations and guidelines is preferred.

Responsibilities

Independently execute analytical testing on drug substance and radioactive drug products, using HPLC, LC-MS, ICP-MS, GC, TLC, and gamma spectroscopy to support development.
With guidance of senior members of the CMC Analytical team, troubleshoot analytical methods, investigate unexpected results for method/instrument performance issues, and work to identify and resolve root causes to ensure accurate, reliable, and reproducible analytical results.
Support the development, optimization and implementation analytical methods for identification, purity assessment, and quantification of peptide precursor and radiopharmaceutical compounds and related impurities.
Support analytical method qualification and tech-transfer activities in accordance with applicable regulatory requirements and internal procedures.
Document analytical activities and results in accordance with applicable procedures, data integrity requirements, and regulatory expectations.
Collaborate with cross-functional teams, including process development, radiochemistry, quality, regulatory including internal and external partners, to support product development and manufacturing activities. Participate in regular cross-site technical exchanges.
Support team communications in disseminating results, which may come in the form of writing reports, presenting at team meetings.
Contribute to the organization and maintenance of the laboratory.