What You’ll Do:

The Director, Analytical Development and Quality Control will provide strategic and technical leadership for the analytical development, qualification, validation, and lifecycle management of analytical methods, and overall analytical control strategy supporting the development and commercialization of sterile parenteral drug products, in support of Kailera’s pipeline. This role is responsible for leading all activities to enable successful regulatory submissions, approval, and product launch.

The successful candidate will bring progressive experience in pharmaceutical or biopharmaceutical analytical development, including demonstrated experience supporting an NDA for a parenteral drug product. The role requires a strong understanding of analytical chemistry, method development and validation, drug product characterization, stability programs, specifications, and regulatory CMC requirements, together with the ability to translate complex analytical data into sound technical and regulatory strategies.

The Director will work cross-functionally with other Technical Operations functions, Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing, and external contract development and manufacturing organizations (CDMOs) and contract testing laboratories. This leader will establish analytical strategies, oversee external laboratory execution, ensure scientific and regulatory rigor, and drive analytical readiness to support clinical and regulatory milestones, NDA approval, and commercial supply.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

• Lead analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products from development through commercialization, including method development, validation, transfer, QC implementation, and commercial support.
• Define and execute analytical CMC strategies, regulatory submissions, and control frameworks, including NDA Module 3 content, analytical data packages, specifications, characterization, validation, stability, and commercial release requirements.
• Ensure scientifically sound, regulatory-compliant analytical programs by leading technical issue resolution, risk management, resource planning, agency interactions, and compliance with FDA, ICH, and pharmacopeial expectations.
• Provide analytical leadership for product characterization, stability, microbiological strategies, quality attributes, commercial manufacturing support, and investigations related to analytical trends, deviations, and product quality issues.
• Establish and maintain robust analytical methods through risk-based qualification, validation, lifecycle management, continuous improvement, troubleshooting, performance monitoring, revalidation, and enhancement of method robustness and efficiency.
• Lead stability and specification strategies across the product lifecycle, ensuring analytical data support shelf life, storage conditions, regulatory commitments, product release, and commercialization objectives.
• Integrate analytical, formulation, process, and manufacturing knowledge to support technology transfer, comparability assessments, change management, and oversight of external analytical laboratories and 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 CMC regulatory filings (IND/NDA/MAA, etc.)
• 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
• Innovative team-player with high energy for our dynamic company environment

Preferred Qualifications:

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

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