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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analytical method development, qualification, and validation for small molecule CMC programs, with a strong focus on impurity characterization and compliance with cGMP requirements. Proven ability to lead cross-functional teams and manage external analytical partners to support regulatory submissions and commercialization readiness.
Highest-signal resume keywords
Analytical Method DevelopmentImpurity CharacterizationGMP Analytical Control StrategiesRegulatory SubmissionsExternal CRO/CMO Management
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 ChemistryMethod ValidationAssay TestingPurity TestingStability AssessmentAnalytical TroubleshootingData InterpretationMethod Lifecycle ManagementAnalytical InvestigationsSpecifications Development
Soft Skills
Technical LeadershipCollaborationFlexibilityCommunication
Tools & Technologies
Quality SystemsReference StandardsCompendial Testing
Industry Keywords
Small Molecule CMCSolid Oral Dosage FormsCGMP RequirementsAnalytical Best PracticesStability Programs
About the role
Key responsibilities & impact- Serve as the Analytical Lead for small molecule CMC programs
- Lead analytical method development, qualification, validation, transfer, and GMP testing across internal teams and external CRO/CMO partners
- Develop and implement phase-appropriate analytical control strategies, specifications, and stability programs
- Provide technical leadership for analytical troubleshooting, data interpretation, impurity characterization, method lifecycle management, and analytical investigations
- Review and approve analytical methods, validation and qualification reports, stability reports, specifications, certificates of analysis, and other CMC documentation
- Direct and manage external CRO/CMO analytical partners
- Support regulatory submissions, commercialization readiness, and product lifecycle management
- Partner with Drug Substance, Drug Product, Quality, Regulatory, Manufacturing, and external teams to strengthen scalable analytical processes
Requirements
What you’ll need- Advanced degree in Analytical Chemistry or a related discipline; PhD preferred, Master’s with significant industry experience considered
- 8+ years of relevant industry experience
- Strong industry experience in analytical development for small molecule drug substances and drug products, including solid oral dosage forms
- Deep knowledge of impurity characterization, assay and purity testing, stability assessment, and GMP analytical control strategies
- Strong understanding of US and EU cGMP requirements and analytical best practices
- Experience supporting CMC development across analytical development, regulatory submissions, method validation and transfer, and commercialization activities
- Experience managing external CRO/CMO analytical networks
- Strong working knowledge of quality systems, reference standards, stability programs, specifications, and compendial testing requirements
- Flexibility and willingness to travel as needed
Benefits
Comp & perks- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance
- AD&D benefits
- Disability benefits
- Voluntary plans to personalize coverage
- Dollar-for-dollar 401(k) matching up to 6% on eligible contributions
- Long-term stock incentives
- ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays
- Company-wide shutdowns