Kailera is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1 therapies to provide options for people living with obesity. Backed by a16z.
About the role
The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.
What they're looking for
- Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy. Experience in the analytical support of drug substance PPQ/Process Validation
- Demonstrated analytical project leadership and cross-functional team participation
- Experience in setting commercial specifications
- Experience in authoring regulatory documents, including NDA experience
- Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements
- Strong understanding of all applicable ICH guidelines
More about this role
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.
- Lead analytical development and support QC activities related to the development and commercialization of...
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