CMC Consultant HiFiBio
CMC Consultant HiFiBio
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Job Description
Job Description
We are currently looking for a technical CMC consultant to support an early phase biotech on a parttime 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 FirstinHuman (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 businessminded 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.
Required Experience:
Contract
Employment Type
Full-Time
