What You’ll Do:

The Associate Director, Analytical Development and Quality Control will support analytical development and Quality Control 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 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
• Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
• Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
• Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
• Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
• Support comparability assessments for process changes, analytical method updates, or site transfers
• Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
• Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
• Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions
• Prepare for audits/inspections and represent analytical and QC functions to regulatory authorities
• Lead, mentor, and develop analytical and QC staff while driving continuous improvement and phase-appropriate analytical strategies

Required Qualifications:

• 10+ years of experience, or 5+ 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, dissolution, along with extractables and leachable analysis
• 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 supporting early- and late-stage CMC development, stability programs, and specification setting
• Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
• Strong track record of working with CROs/CMOs and managing external analytical/testing activities
• Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
• Demonstrated leadership ability with experience mentoring and developing scientific staff
• Strong communication, cross-functional collaboration, and project-management skills
• Innovative team-player with high energy for our dynamic company environment

Preferred Qualifications:

• Prior peptide product development including familiarity with peptide manufacturing, characterization, formulation, and stability experience is preferred

Education:

• A bachelor’s degree with 10+ years or an advanced degree with 5+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field

Additional Information:

• This position requires some travel to domestic and international destinations
• This position requires working in environments where there may be specific gowning or dress code requirements