Job Details

Senior Scientist, Analytical Development (Drug Substance)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:The Principal Analytical Scientist will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Principal Analytical 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.Preferred location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).Responsibilities:

• Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs).
• Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards.
• Perform detailed review and provide data integrity oversight of data generated at CDMOs.
• Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes.
• Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements.
• Oversee stability programs to support product shelf-life and expiration dating.
• Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs).
• Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data.
• Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations.
• Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.).
• Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing.
• Provide technical guidance and support to internal teams and external partners.
• Oversee the preparation and review of technical documents, including protocols, reports, and SOPs.
• Ensure data integrity and traceability in all analytical documentation.Required Qualifications:
  • Proven experience with peptides and small molecules in both injectable and solid oral dosage forms.
  • Experience managing outsourced activities with CDMOs.
  • Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, and spectroscopic methods.
  • Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development.
  • Effective communication and interpersonal skills.
  • Ability to work effectively in a fast-paced, collaborative environment.Education:
    • Ph.D. or MS degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field, or a BS degree with a commensurate amount of directly applicable industry experience.
    • Ph.D./MS with a minimum of 6 years or BS with a minimum of 8 years of experience in analytical development and quality control within the pharmaceutical or biotech industry.Benefits of Working at Kailera:
      • Comprehensive health benefits and tax-advantaged savings accounts
      • Flexible time off, 13 paid holidays, and a companywide year-end shutdown
      • Monthly wellness stipend
      • Generous 401(k) match
      • Disability and life insuranceAt Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.Salary Range: $115,000 - $140,000 USDEQUAL EMPLOYMENT OPPORTUNITY INFORMATION:Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age (40 and over), sex or gender, gender identity or expression, 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.Apply for this job
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