Senior Scientist - Process Development Chemist

23h23 hours ago

Kailera Therapeutics, Inc.

Waltham, US · Full-time · $143,000 – $175,000

About this role

At Kailera Therapeutics, we are bold, authentic, and committed to developing therapies that transform lives and elevate health for obesity and related conditions. Rooted in entrepreneurial spirit and team-oriented culture, we seek a Senior Scientist, Process Development Chemist with experience in small molecule and/or peptide manufacturing. This role demands deep process development expertise, technical ownership, and strong synthetic and analytical chemistry background.

You will support drug substance process development for complex, multistep manufacturing at external CMOs. Partner with senior leads on scale-up, process characterization, and PPQ activities. Review, analyze, and interpret development and manufacturing data to inform technical decisions.

Collaborate cross-functionally with Analytical Development, Quality, Regulatory, and Supply Chain to meet program milestones. Provide technical oversight during technology transfer, GMP manufacturing, and validation at CMOs. Participate in meetings, troubleshoot issues, and support root cause investigations in a fast-paced, externally focused model.

Contribute to robust process control strategies aligned with CMC and GMP expectations. Author and review technical documentation like development reports and validation summaries. Join our expanding team in an inclusive workplace promoting collaboration, integrity, and excellence, with hub-based onsite work in Waltham, MA 3-4 days per week.

Requirements

PhD in Organic Chemistry, BS/MS in Chemical Engineering with a strong background in organic chemistry with 5-8 years of relevant pharmaceutical or biotechnology industry experience
Experience supporting small molecule and/or peptide drug substance process development, scaleup, or GMP manufacturing in a CMO or virtual development environment
Exposure to late-stage development activities such as process characterization, validation, or PPQ support
Working knowledge of CMC requirements, GMP principles, and regulatory expectations
Ability to critically evaluate external data, identify risks, and communicate technical conclusions clearly
Strong collaboration, communication, and organizational skills
Comfort working in a fast-paced, highly cross-functional, externally focused operating model

Responsibilities

Support drug substance process development activities for complex, multistep manufacturing processes executed at external CMOs
Partner with senior technical leads to support scale-up, process characterization, and Process Performance Qualification (PPQ) activities
Review, analyze, and interpret development, scaleup, and manufacturing data generated by CMOs to support technical decision making
Contribute to the development and implementation of robust process control strategies aligned with CMC and GMP expectations
Author and review technical documentation including development reports, manufacturing summaries, and supporting validation documentation
Support technology transfer and technical oversight of external CMOs during development, GMP manufacturing, and validation activities
Participate in CMO meetings, troubleshoot technical issues, and support root cause investigations and corrective actions
Collaborate cross-functionally with Analytical Development, Quality, Regulatory, and Supply Chain to support program milestones