Note: The job is a remote job and is open to candidates in USA. Kailera Therapeutics is developing novel therapies for obesity and related conditions. The Director will lead analytical development, quality control strategy, and lifecycle management for sterile parenteral products, supporting regulatory submissions, approval, and commercial launch. The role works cross-functionally and oversees external laboratories and partners to ensure scientific and regulatory readiness.
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
Skills
- 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
- 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
- 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
Benefits
- Comprehensive health coverage
- Flexible time off
- Paid holidays
- A year-end shutdown
- A monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability and life insurance
- Annual bonus opportunities
- Equity grants
- 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).
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