What You’ll Do:

The Director, Analytical Development and Quality Control will oversee quality control operations throughout clinical development and commercialization for Kailera’s pipeline compounds. This role is responsible for developing and executing robust QC strategies supporting GMP release, stability programs, and data integrity for drug substances and drug products (injectable and solid oral dosage forms).

Key responsibilities include management and technical oversight of external testing activities, stability study management, and implementation of advanced data trending and reporting tools to ensure compliance and timely delivery. This position will play a key role in ensuring that critical analytical data are delivered in alignment with integrated development plans and program timelines.

Required location: Waltham, MA or San Diego, CA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Develop phase-appropriate QC strategies, procedures (SOPs), and workflows to support QC operations within the CMC team supporting clinical programs from early development through commercialization
• Design, implement, and manage stability programs for drug substances and drug products, including protocol development, execution, trending, and reporting
• Utilize stability trending and statistical analysis software (e.g., JMP, SLIMStat) to monitor product performance and predict shelf-life
• Oversee QC activities at CDMOs and third-party testing sites, ensuring cGMP compliance, data integrity, and timely release and stability testing
• Establish robust data management practices for QC, including electronic systems for data capture, trending, and archival, to support regulatory submissions
• Ensure QC activities align with integrated development timelines and global regulatory expectations (ICH, USP, EP, JP)
• Provide QC support for investigations (OOS/OOT), deviations, CAPAs, and change controls
• Prepare for audits and inspections, representing QC to regulatory authorities
• Collaborate cross-functionally with CMC, QA, and Regulatory teams to ensure accurate QC documentation (SOPs, CoAs, protocols, reports)
• Strong, demonstrated ability to work effectively in teams and collaborate cross-functionally
• Perform data verification of regulatory submissions (IND, IMPD, and NDA)
• Lead, mentor, and develop QC staff while driving continuous improvement and phase-appropriate analytical strategies

Required Qualifications:

• Bachelor’s degree and 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 CMC regulatory filings (IND/NDA/MAA, etc.)
• Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, and dissolution
• Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• Hands-on experience managing QC activities performed at CDMOs and third-party testing sites, with an emphasis on release and stability testing
• Experience with stability-trending software
• Proven experience supporting OOS/OOT investigations, deviations, CAPAs, and change controls
• Strong track record of working with CROs/CMOs and managing external QC activities
• Demonstrated leadership ability with experience mentoring and developing staff
• Strong communication, cross-functional collaboration, and project-management skills
• Innovative team-player with high energy for our dynamic company environment

Preferred Qualifications:

• Prior experience implementing internal QC control strategies supporting development of peptide sterile injectable/combination drug products and small molecule solid oral dosage forms
• Prior experience in development QC processes and workflows to enable efficient implementation of QC control strategies and data integrity

Education:

• A 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