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Posted: 10/19/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading Stability Operations for Biologics, Vaccines, and Small Molecule programs, with a strong focus on clinical stability study design, execution, and compliance with global regulations. Proven ability to manage cross-functional teams and drive digital modernization initiatives within a GxP environment.
Highest-signal resume keywords
Ph.D. In Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Or Chemical EngineeringClinical Stability Study Design And ExecutionGlobal Stability Regulations Knowledge (ICH, FDA, EMA)Leadership In Cross-Functional TeamsDigital Transformation Experience Using RLIMS2
About the role
Key responsibilities & impact- Provide strategic, scientific, and operational leadership for an end-to-end Stability Operations model across Biologics, Vaccines, and Small Molecule programs
- Lead a Stability Operations team responsible for clinical stability study planning, execution, monitoring, data readiness, and operational governance
- Partner with analytical development, External Capabilities, Quality, and program teams to identify stability risks and design clinical stability programs
- Define stability-facing roles, responsibilities, governance, and ownership boundaries across internal and external groups
- Establish and lead cross-divisional forums connecting Research & Development and Manufacturing for stability transitions through validation, PPQ, registration, and launch
- Oversee stability content supporting IND, IMPD, NDA, and BLA filings, including data presentation and shelf-life justification strategies
- Champion digital modernization, including RLIMS2 utilization, CRO stability data workflows, automated reporting, structured data intake, and data visualization
- Drive global capacity through capital build, chamber governance, inventory visibility, and space optimization
- Manage approximately 25 people and support their scientific, personal, and leadership development, including succession planning
- Ensure compliance with Quality Management System expectations, safety procedures, training requirements, and operational compliance metrics
- Build partnerships across R&D, Manufacturing, Quality, Digital CMC, analytical development, commercial stability, and external teams
Requirements
What you’ll need- Ph.D. degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering, or related scientific discipline with 8+ years of relevant experience; or MS degree with 12+ years of relevant experience; or BS degree with 14+ years of relevant experience
- Extensive experience designing, executing, and defending clinical stability study strategies for Biologics, Vaccines, or Small Molecule programs
- Strong understanding of global stability regulations and expectations, including ICH, FDA, EMA, and related CMC requirements
- Demonstrated experience guiding assets across the clinical-to-commercial boundary, including late-stage development, validation, PPQ, launch readiness, or BLA/NDA filing execution
- Proven leadership in cross-functional, highly matrixed technical forums and ability to influence stakeholders across research, development, manufacturing, quality, regulatory, and external partner organizations
- Experience applying quality principles, deviation management expectations, inspection readiness practices, and compliant documentation standards within a GxP-facing scientific environment
- Aptitude for managing inclusive scientific and operational teams and attracting, developing, and retaining diverse talent
- Excellent verbal and written communication skills and ability to excel in a team-based, fast-paced, highly dynamic environment
- Preferred: experience across Biologics, Vaccines, and Small Molecules
- Preferred: digital transformation experience using RLIMS2, Benchling, Signals, GLIMS, automated data pipelines, or structured regulatory authoring systems
- Preferred: operational governance, standardized ways of working, and continuous improvement experience
- Preferred: training curricula, technical leader mentoring, and subject matter expert development experience
- VISA Sponsorship: Yes
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement
- Visa sponsorship
- Relocation: Domestic/International
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Stability Study StrategiesRegulatory Filing Execution (IND, IMPD, NDA, BLA)Quality Management System ComplianceDeviation ManagementInspection Readiness Practices
Soft Skills
Excellent Verbal And Written CommunicationTeam Leadership And DevelopmentStakeholder InfluenceInclusive Team Management
Tools & Technologies
RLIMS2BenchlingSignalsGLIMSAutomated Data Pipelines
Industry Keywords
BiologicsVaccinesSmall MoleculesGxPOperational Governance