Senior Scientist, Process Development Chemist

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.

What You’ll Do:

We are seeking an experienced Senior Scientist, Process Development Chemist with experience in the area(s) of small molecule and/or peptide manufacturing to participate in development and commercialization activities for a complex drug substance program. This role requires deep process development expertise, strong technical ownership, and a strong background in synthetic and analytical chemistry.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

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
• Ensure clear documentation, data integrity, and compliance with regulatory and quality expectations across external partners

Required Qualifications:

• 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

Preferred Qualifications:

• Experience working directly with external CMOs and contract laboratories
• Exposure to regulatory submissions or inspection readiness activities
• Familiarity with Quality-by-Design (QbD), risk assessments, and control strategy development
• Experience supporting development or commercialization programs in a virtual biotech organization
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Education:

PhD in Organic Chemistry, or BS/MS in Chemical Engineering with a strong organic chemistry background, (Advanced degree preferred; equivalent experience will be considered)

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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