Principal External Manufacturing Specialist (Advanced Therapies)
Regeneron · Tech Valley
CMCFull-time$92k–$151kCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
What they're looking for
- Bachelor's degree in scientific discipline with 8+ years cGMP manufacturing operations experience
- Experience in small molecule synthetic chemistry and/or siRNA therapy
- Knowledge of bulk manufacturing techniques: chemical synthesis, purification, annealing, lyophilization
- Understanding of cGMP, FDA regulations, ICH guidelines, and EU regulatory compliance
- Demonstrated ability to lead continuous improvements and system implementations
- Strong written, oral, and interpersonal communication skills
What you'll be doing
- Serve as primary operational contact for contract manufacturing sites and partner organizations
- Coordinate external manufacturing activities including batch scheduling, materials supply, and cycle time tracking
- Function as liaison between internal departments and external manufacturers for quality and operations
- Lead sub-team initiatives in process improvements, equipment implementation, and strategy development
- Monitor cGMP compliance and support investigations of external manufacturing and shipping operations
Privacy & handoff
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