Found Description
We are currently looking for a Principal Scientist Tech Ops (CMC Science) to join our global team in Bern.
Key Responsibilities
- Contribute to the development and implementation of phase‑appropriate CMC strategies.
- Support CMC activities for assigned programs from early development through late‑stage clinical development.
- Identify risks and develop mitigation strategies to ensure timelines and quality standards are met.
- Support drug substance and drug product development activities.
- Support analytical method development, validation, and specification setting.
- Support process characterization, validation, and lifecycle management.
- Manage relationships with CDMOs and manufacturing partners.
- Support technology transfer and scale‑up activities.
- Ensure compliance with GMP requirements.
- Author, review, and contribute to CMC sections of regulatory submissions (IND, CTA, NDA, BLA). <...
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