Kailera Therapeutics · 2 weeks ago
Associate Director, Analytical Development and Quality Control
United States
Full-time
Remote
Lead/Staff
$155K/yr - $190K/yr
10+ years expKailera Therapeutics is committed to developing therapies that empower individuals to transform their lives and improve their health. The Associate Director, Analytical Development and Quality Control will oversee analytical development and quality control operations for clinical development and commercialization of the company's pipeline compounds, ensuring seamless execution of drug development and manufacturing activities.
BiotechnologyPharmaceuticalTherapeutics
No H1B
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 on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
Collaborate with cross-functional line functions to ensure CMC and program goals are met
Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight
Qualification
Required
A bachelor's degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
Or an advanced degree with 5+ years
Knowledge of peptide chemistry is required
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
Innovative team-player with high energy for our dynamic company environment
Preferred
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
Benefits
Comprehensive health coverage
Flexible time off
Paid holidays
A year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Tuition reimbursement
Commuter benefits
Disability and life insurance
Annual bonus opportunities
Equity grants
Company
Kailera Therapeutics
Kailera Therapeutics develops next-generation injectable and oral therapies for chronic weight management.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1BKey Investors
Bain Capital Private EquityAtlas Venture,Bain Capital Life Sciences,RTW Investments
2026-04-17IPO
2025-10-14Series B· $600M
2024-10-01Series A· $400M
Leadership Team
Ronald Renaud
President & CEO
Paul Burgess
Chief Operating Officer and Chief Business Officer
Recent News
Globe and Mail
2026-08-04
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-07-25
2026-07-21
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