Analytical Science Lead
vor 7 Stunden
At Roche, we're pushing the boundaries of healthcare to bring life-changing treatments to people around the world. As a Scientific Expert, you'll play a pivotal role in our Global Device MSAT organization, leading efforts to strengthen and expand our Device capabilities.
The OpportunityWe're seeking a highly skilled and experienced senior technical and strategic manager to oversee industrialization and sustaining engineering capabilities. You'll be responsible for implementing robust analytical science and technology, ensuring high-quality standards for controlling and testing starting materials, intermediates, drug substances, and products manufactured by CDMOs for Roche.
Key Responsibilities:- Serve as the analytical lead for method transfers and validations at manufacturing sites.
- Act as the person-in-plant during critical project phases, including validation and registration preparation.
- Support manufacturing sites during pre-approval inspections to ensure compliance with regulatory requirements.
- Collaborate with CMC groups, late-stage technical development, and commercial quality control teams to facilitate analytical technology transfers.
To succeed in this role, you'll need an advanced degree in Analytical Chemistry, Chemistry, or a related scientific discipline, along with extensive experience in analytical method development and transfers in a commercial manufacturing environment. Strong knowledge of GMP and regulatory requirements is also essential.
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