Kailera Therapeutics, Inc.
pharmaceuticaliotech
AssociateDirector,AnalyticalDevelopmentandQualityControl
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“Associate Director, Analytical Development and Quality Control at Kailera Therapeutics, Inc.. Skills: Analytical Development, Quality Control, Regulatory Filings. Support analytical development and QC activities. Maintain current knowledge in analytical methods”
What You'll Achieve.
Ensure end-to-end drug development and manufacturing activities are executed seamlessly; Ensure adequate development and execution of CMC plan/strategies; Ensure CMC and program goals are met
Industry & Context.
Sound problem-solving skills; Technically driven decision-making ability
Travel to domestic and international destinations, Working in environments with specific gowning or dress code requirements
What They're Looking For.
Must Have
Bachelor's degree and 10+ years of experience in the pharmaceuticaliotech industry, Experience in all phases of innovative drug development and commercial launch, Knowledge of peptide chemistry, Demonstrated project and cross-functional team participation, Experience in authoring regulatory documents, Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements, Experience with oversight of the analytical activities at CDMOs and/or CTLs, Sound problem-solving skills with technically driven decision-making ability, Effective written and verbal communication and interpersonal skills
Nice to Have
Advanced degree with 5+ years of experience, Knowledge and experience in analytical development of peptide therapeutics (DS and DP), Knowledge and experience in analytical development of injectable products, and associated control strategies
What You'll Do.
Support analytical development and QC activities
Maintain current knowledge in analytical methods
Support development of analytical methods
Provide input for developing strategies
Support authoring of relevant CMC sections
Participate on cross-functional CMC teams
Communicate CMC project status
Collaborate with cross-functional line functions
Travel to CDMOs for oversight
How You'll Work.
Team & Collaboration
Work closely with cross-functional stakeholders; Participate on cross-functional CMC teams; Communicate project status cross-functionally; Collaborate with cross-functional line functions
Communication Scope
Effective written and verbal communication; Interpersonal skills
Process & Methodology
Manage execution of functional activities
Full Job Description
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 Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) Responsibilities: Support analytical development and QC activities related to characterization of peptide drug substances and drug products from early-stage clinical development through commercialization Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms Support development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization Support authoring of relevant CMC sections to enable global regulatory filings Participate
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