About the Role
Leads technical aspects of analytical development within drug substance and product teams, ensuring robust data packages and regulatory compliance across global projects.
Responsibilities
- Lead analytical contributions to drug development programs
- Provide scientific expertise in method development and validation
- Support regulatory filings with accurate and compliant data
- Guide analytical strategy from early development through commercialization
- Collaborate with cross-functional teams on project timelines
- Oversee transfer of analytical methods to manufacturing sites
- Ensure adherence to quality standards and regulatory requirements
- Mentor junior scientists in technical and regulatory best practices
- Evaluate new analytical technologies for potential implementation
- Troubleshoot complex analytical challenges across development stages
- Represent analytical science in project team meetings
- Drive continuous improvement in laboratory processes
- Coordinate with external partners on analytical deliverables
- Maintain up-to-date knowledge of regulatory guidelines
- Contribute to technical risk assessments for development plans
- Support inspection readiness for analytical data packages
- Lead root cause analyses for out-of-specification results
- Develop and review technical protocols and reports
- Ensure data integrity across analytical documentation
- Promote scientific rigor within the analytical team
- Align analytical strategies with overall program goals
- Facilitate knowledge sharing across technical groups
- Optimize resource use in analytical project execution
- Champion innovation in analytical approaches
- Ensure timely delivery of analytical milestones
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model with flexibility
Team
Part of the Global Analytical Development team
Why Join Us
- Opportunity to work on innovative therapies with global impact
- Inclusive culture that values diverse perspectives
- Professional growth in a science-driven environment
- Collaborative teams focused on patient-centered outcomes
What We Offer
- Flexible working arrangements to support work-life balance
- Comprehensive health and wellness benefits
- Pension and insurance plans
- Learning and development programs
- Employee stock purchase options
Available for eligible candidates
