Kailera Therapeutics, Inc.
pharmaceutical or biotech
SeniorScientist,AnalyticalDevelopmentandQualityControl
“Senior Scientist, Analytical Development and Quality Control at Kailera Therapeutics, Inc.. Skills: Analytical Development, Quality Control, cGMP Manufacturing, Regulatory Compliance. Support analytical development. Support quality control activities”
What You'll Achieve.
ensure the integrity of data generated by our external partners; ensure compliance with global regulatory standards; support product retest, shelf-life, and expiration dating; generate data to justify specification limits; assess trends in stability data; ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations
Industry & Context.
internal and external investigations of quality events (e. g. , deviations, CAPAs, OOS, etc. )
What They're Looking For.
Must Have
PhD 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 small molecules in both injectable and solid oral dosage forms, Experience managing outsourced activities with CDMOs, 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, Proven effective communication and interpersonal skills, Ability to work effectively in a fast-paced, collaborative environment
Nice to Have
Experience with combination drug/device presentations, Experience with establishing peptide drug substance analytical control strategy for various peptide synthesis modalities (linear SPPS, hybrid approaches, LPPS, and/or recombinant)
What You'll Do.
Support analytical development
Support quality control activities
Oversee analytical activities
Perform detailed review
Provide data integrity oversight
Ensure methods are developed
Provide oversight of method validation
Oversee stability programs
Contribute to data summaries
Ensure analytical methods meet requirements
Generate data to justify limits
Assess trends in stability data
Ensure activities comply with regulations
Participate in investigations
Generate cGMP compliant data
Provide technical guidance
Oversee preparation of technical documents
How You'll Work.
Team & Collaboration
Work directly with technical counterparts at vendor sites; Work closely with Manufacturing and Quality Assurance teams; Provide technical guidance and support to internal teams and external partners
Communication Scope
Proven effective communication and interpersonal skills
Process & Methodology
Manage outsourced activities with CDMOs
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