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 Director, Analytical Development and Quality Control will provide strategic and technical leadership for the analytical development, qualification, validation, and lifecycle management of analytical methods, and overall analytical control strategy supporting the development and commercialization of sterile parenteral drug products, in support of Kailera’s pipeline. This role is responsible for leading all activities to enable successful regulatory submissions, approval, and product launch. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, CCIT, device testing, etc
- Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
- Strong track record of working with CROs/CMOs and managing external analytical development and QC activities
- Demonstrated leadership ability with experience mentoring and developing staff
- Strong communication, cross-functional collaboration, and project-management skills
- Innovative team-player with high energy for our dynamic company environment
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 Director, Analytical Development and Quality Control will provide strategic and technical leadership for the analytical development, qualification, validation, and lifecycle management of analytical methods, and overall analytical control strategy supporting the development and commercialization of sterile parenteral drug products, in support of Kailera’s pipeline. This role is responsible for leading all activities to enable successful regulatory submissions, approval, and product launch.
The successful candidate will bring progressive experience in pharmaceutical or biopharmaceutical...
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