What You’ll Do:

Playing a senior leadership role within the Technical Operations organization, the Vice President, Analytical Development and Quality Control position will be accountable for analytical development and QC operations in support of clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical, organizational, and strategic leadership, 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 integrated development plan and program timelines. The individual will also play a critical role in, and participate in, the overall CMC strategy planning and execution.

Required location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• Serve as Kailera’s most senior subject matter expert on all analytical development and QC activities related to characterization of drug substances and drug products from early to late-stage clinical development through commercialization
• Maintain current knowledge in analytical control strategies supporting a variety of molecule platforms and dosage forms
• Ensure delivery of complex technologies and analytical methods that support Kailera’s product pipeline, including supporting analytical transfers and troubleshooting in laboratories across the globe
• Be accountable for analytical development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization
• Author/review/approve relevant CMC sections to enable global regulatory filings
• Lead cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
• Serve as a project core team member and communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making
• Collaborate with cross-functional line functions (Drug Substance, Drug Product, Supply Chain, Quality, CMC regulatory, CMC Operations, Clinical, and Program Management) to ensure CMC and program goals are met
• Lead the efforts to assess/identify/engage potential suppliers for analytical development and QC services in support of drug substance and drug product development and manufacturing with adequate risk assessment
• Travel to CDMOs and other service providers for vendor assessment and qualification, as well as oversight of analytical activities as needed
  
  

Required Qualifications:

• 15 + years of experience in the pharmaceutical/biotech industry with extensive experience in late-phase innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
• Experience with analytical characterization of peptides in sterile formulations and small molecules in oral formulations is required
• Proven track record of strategic leadership and management with the ability to manage and develop high-performing teams
• Demonstrated strong project and cross-functional team leadership
• Thorough understanding and working knowledge of drug development and manufacturing activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• Extensive working experience with management and oversight of the analytical activities at CDMOs and/or stand-alone analytical testing laboratories
• Strong problem-solving skills with strategic and sound, technically driven decision-making ability
• Effective written and verbal communication and interpersonal skills
• Innovative team-player with high energy for our dynamic company environment
  
  

Education:

• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
  
  

Additional Information:

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