Associate Director, Projects & Strategy, Analytics, Science & Technology (AS&T)
Tasks
- Align analytical control strategy with Regulatory Affairs CMC and Quality
- Coordinate analytical deliverables across internal teams and external partners
- Lead analytical activities and manage project communications timelines risks
- Maintain end to end ownership of analytical components for CMC Module 3 dossier
- Represent analytical function in cross functional teams
Perks/Benefits
- 401-k match
- Commuting allowance
- Critical illness insurance
- Discounted insurance
- Employee assistance program
- HSA/FSA
- Life and AD D Insurance
- Medical/Dental/Vision insurance
- Paid time off
- Parental leave
- Professional development
- Subsidized parking
- Tuition reimbursement
Skills/Tech-stack
Analytical Control Strategy | Analytical Development | Antibody drug conjugates | BLA Preparation | CMC | Control strategy | EMA Requirements | FDA requirements | GMP | Good Manufacturing Practice | Monoclonal antibodies | Multi Specific Antibodies | Ph Eur | Project Management | Regulatory Affairs | Stakeholder management | USP
Education
Bachelor of Science | Doctor of Philosophy | Master of Science
Roles
Associate | Associate Director | Director | Manager | Program Manager
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