BridgeBio is a biotechnology company designing transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Backed by Sequoia.
About the role
BridgeBio seeks a motivated, knowledgeable, and hands-on analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to the development of clinical assets and regulatory submissions. This position requires close collaboration with the Drug Substance, Drug Product, and Quality Assurance groups. This candidate should know the various analytical techniques across modalities.
What they're looking for
- Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries
- Independently proficient in a variety of analytical techniques in support of biologic and small molecule development
- Ability to communicate effectively with vendors regarding project scope, scientific results and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals
- Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
- Subject matter expertise in stability program management, including protocol design, data trending and analysis (e.g., using JMP), and shelf-life assignment/extension
- Proficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS
More about this role
Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
BridgeBio seeks a motivated, knowledgeable, and hands-on analytical development scientist and quality control professional to manage analytical development, QC, and...
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