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 Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners.
What they're looking for
- D. with a minimum of 6 years, MS with a minimum of 10 years, or BS with a minimum of 12 years of experience in analytical development and quality control within the pharmaceutical or biotech industry
- Proven experience with peptides and/or small molecules in solid oral dosage forms
- Experience managing outsourced activities with CDMOs
- Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, dissolution, and spectroscopic methods
- Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development
- Proven effective communication and interpersonal skills
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 Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards.
Required location: Waltham, MA (hub-based, onsite 3-4...
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