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Posted: 10/20/2026Director – Analytical Development, Quality Control
Kailera TherapeuticsPosted 10/20/2026full-timeWaltham • Massachusetts • United StatesLead💰 $192,000 - $235,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical development, qualification, and lifecycle management of analytical methods for sterile injectable products, ensuring compliance with FDA and ICH guidelines. Proven ability to lead cross-functional teams and manage external partnerships to drive successful regulatory submissions and product commercialization.
Highest-signal resume keywords
Analytical Development LeadershipHPLC/UPLC ExpertiseRegulatory Submissions (NDA/IND/MAA)CGMP ComplianceCross-Functional Collaboration
About the role
Key responsibilities & impact- Provide strategic and technical leadership for analytical development, qualification, validation, and lifecycle management of analytical methods
- Lead analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products from development through commercialization
- Define and execute analytical CMC strategies, regulatory submissions, and control frameworks, including NDA Module 3 content and analytical data packages
- Lead method development, validation, transfer, QC implementation, stability programs, specifications, characterization, and commercial release activities
- Lead 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
- Establish and maintain analytical methods through qualification, validation, lifecycle management, troubleshooting, monitoring, revalidation, and continuous improvement
- Lead stability and specification strategies supporting shelf life, storage conditions, regulatory commitments, product release, and commercialization
- Support technology transfer, comparability assessments, change management, and oversight of external analytical laboratories and partners
- Work cross-functionally with Technical Operations, Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing, CDMOs, and contract testing laboratories
- Drive analytical readiness for clinical and regulatory milestones, NDA approval, product launch, and commercial supply
Requirements
What you’ll need- 10+ years of experience in the pharmaceutical/biotech industry, or 8+ years with an advanced degree
- Experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings, including IND/NDA/MAA
- Strong expertise in analytical techniques including HPLC/UPLC, LC–MS, SE-HPLC, CCIT, and device testing
- Knowledge of cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
- Strong track record 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
- Bachelor's degree with 10+ years or 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 preferred
- Experience supporting commercial products preferred
- Knowledge of combination product testing and control strategy is a plus
Benefits
Comp & perks- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability insurance
- Life insurance
- Annual bonus opportunities
- Equity grants
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Analytical Method DevelopmentValidation and QualificationStability ProgramsRisk ManagementQuality Control ImplementationMicrobiological StrategiesDevice TestingComparability AssessmentsChange ManagementTechnical Issue Resolution
Soft Skills
LeadershipMentoringProject ManagementCommunicationCollaboration
Industry Keywords
Pharmaceutical IndustryBiotech IndustryCRO ManagementCMO ManagementQuality SystemsICH GuidelinesUSP/EP/JP/CHP RequirementsPeptide Drug ProductsCombination ProductsAnalytical CMC Strategies