Janux Therapeutics develops immunotherapies that generate immune responses to prevent tumors and not affect a patient’s healthy tissue. Janux technology targets all three stages of the anti-tumor immune response. Backed by Correlation Ventures.
About the role
We are seeking a highly skilled and motivated Principal Scientist to join our Analytical and Formulation Development team. The successful candidate will lead and oversee analytical and formulation development activities for our pipeline of therapeutic candidates in immuno-oncology and autoimmune disease. This role requires a deep understanding of analytical methodologies, formulation development of biologics, regulatory requirements, as well as experience managing analytical development and QC activities at CDMOs.
What they're looking for
- Extensive experience in analytical method development, validation, and troubleshooting
- Proven track record in formulation development for protein therapeutics
- Strong knowledge of regulatory requirements (FDA, Ph. Eur., ICH) and cGMP guidelines
- Experience with advanced analytical techniques utilized in drug development for biologics
- Familiarity with Quality by Design (QbD) principles and risk-based approaches
- Must have experience in managing external CROs and CMOs
More about this role
We are seeking a highly skilled and motivated Principal Scientist to join our Analytical and Formulation Development team. The successful candidate will lead and oversee analytical and formulation development activities for our pipeline of therapeutic candidates in immuno-oncology and autoimmune disease. This role requires a deep understanding of analytical methodologies, formulation development of biologics, regulatory requirements, as well as experience managing analytical development and QC activities at CDMOs.
- Responsible for the development and qualification/validation of analytical methods for drug substances and drug products at CDMOs.
- Design and execute formulation development studies to support preclinical and clinical programs.
- Oversee stability studies and ensure compliance with regulatory guidelines.
- Provide oversight of reference standard or reference material programs.
- Collaborate with cross-functional teams including Research, Quality, and Regulatory Affairs, to advance projects from early development through commercialization.
- Provide technical leadership and mentorship to junior scientists and research associates.
- Author and review technical reports...
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