CMC Consultant HiFiBio

We are currently looking for a technical CMC consultant to support an early phase biotech on a part-time basis. The consultant will drive CMC activities into FIH; this is a critical role brought drive key CMC changes when hitting the clinic, managing international manufacturing relationships and support preparation for First-in-Human (FIH) studies and IND filings.

Responsibilities:

- Lead all technical CMC activities for FIH trials.
- Manage external manufacturing partnerships, including Chinese CMOs.
- Provide regulatory CMC expertise across technical writing, IND strategy, and agency interactions.
- Provide strategic advice on CMC operations with a business-minded approach, balancing technical rigor with entrepreneurial flexibility.

Requirements:

- 15+ years of CMC experience in biologics, particularly antibodies and bispecifics.
- Strong technical CMC expertise, with proven FIH/IND filing experience.
- Experience managing external manufacturing organizations (CMOs), especially in China.
- Ability to work remotely and independently, across time zones.
- Strong business mindset, able to combine bureaucratic attention to regulatory detail with commercial pragmatism.
- Prior experience working with small biotech and big pharma is highly desired.