Reporting:
Senior Scientist I, CMC Analytical Development
Description:
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.
Illustrative Breadth of 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.
Requirements/Skills:
- 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. Experience working with radiopharmaceuticals is preferred; experience with non-radioactive compounds in analytical development is also highly valued.
- Proficiency in analytical techniques such as HPLC, iTLC, and related analytical technologies required.
- 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.
- 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.
- Good understanding of the radiation safety regulations and guidelines is preferred.
- Strong communication and teamwork skills, with the ability to effectively communicate analytical results, technical issues.
Mariana Oncology Compensation Summary:
The salary for this position is expected to range between $93,800 and $174,200 per year. Your compensation will also include a performance-based cash incentive.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and will be reviewed periodically upon joining Mariana Oncology. Mariana may change the published salary range based on company and market factors.
