Head of Analytical Development Biologics
hace 2 semanas
Job Summary: We are seeking a highly experienced and skilled professional to lead our analytical development team for late stage biologics. The successful candidate will be responsible for overseeing and managing phase-appropriate analytical development for clinical trial material efforts, contributing to product development from Pharmaceutical Sciences to Commercialization, and implementing externalization activities with external partners.
Key Responsibilities:
- Direct and indirect supervisory responsibilities in analytical areas for development of high-quality late stage biologics therapeutics.
- Drive global late stage team to obtain scientific data; data compilation and review; preparation and review of technical reports, global regulatory filings, and other documentation.
- Collaborate with other functions in Pharmaceutical Sciences to encourage strategic alignment and successful achievement of shared goals.
- Develop, implement and execute a smart sourcing strategy.
- Manage functional area budget and human resources to be within required limits.
- Drive continuous improvement in the technology, methodology and business processes used to support analytical development.
Requirements:
- Master or PhD in chemistry, biology, pharmacy, or related pharmaceutical science.
- At least 10 years relevant industry experience.
- Leadership experience of teams including managers and scientists.
- Direct experience in analytical development for biologics, especially late stage assets.
- Drive decision making within a cross-functional, cross-cultural global team structure.
Travel Requirements: Approximately 10-15% travel is required, including domestic and international flights with overnight stays.
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