Director, Analytical Development and Quality Control

The role

The Director, Analytical Development and Quality Control provides strategic and technical leadership for analytical development, qualification, validation, and lifecycle management of analytical methods. This role supports the development and commercialization of sterile parenteral drug products to enable regulatory submissions and product launch.

What you will do

• Lead analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products.
• Define and execute analytical CMC strategies, regulatory submissions, and control frameworks.
• Ensure regulatory-compliant analytical programs by leading technical issue resolution and agency interactions.
• Provide analytical leadership for product characterization, stability, and microbiological strategies.
• Establish and maintain robust analytical methods through qualification, validation, and lifecycle management.
• Lead stability and specification strategies across the product lifecycle.
• Integrate analytical, formulation, process, and manufacturing knowledge to support technology transfer and oversight of external partners.

Required qualifications

• 10+ years of experience, or 8+ with advanced degree, in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global
• Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, CCIT, device testing, etc.
• Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• Strong track record of working with CROs/CMOs and managing external analytical development and QC activities
• Demonstrated leadership ability with experience mentoring and developing staff
• Strong communication, cross-functional collaboration, and project-management skills
• Bachelor’s degree with 10+ years or an advanced degree with 8+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field

Nice to have

• Prior experience supporting development of peptide sterile injectable/combination drug products
• Experience supporting commercial products
• Knowledge of combination product testing and control strategy

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

Before you apply

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

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.