Senior Director CMC
Executive Director CMC - Remote
This is an opportunity to work for a Clinical Stage Biopharmaceutical company with a key focus on Bone, Muscle & Joint Diseases, and they are actively seeking an Executive Director of CMC to join their business remotely, on a permanent basis.
Responsibilities
- Leads all CMC activities, including Tech Transfer, Product Launch, Quality Control & More
- Collaborate with Regulatory, Clinical & other teams to get product to market and meet timely deadlines
- Define requirements for CMO, choose and develop relationship with said CMOs
- Define key metrics & KPIs for CMC department, be accountable for these and report to the CTO on frequent basis
- Author CMC sections of BLA submissions
Requirements
- Extensive background as Senior/Executive Director in a CMC position in the Biologics space (cGMP)
- CDMO selection & management background with experience in Tech Transfer
- Both Drug Substance (DS) & Drug Product (DP) experience with broad CMC leadership
- Been part of a successful BLA
- Fluent in English (Knowledge of Korean would be beneficial)
If this is a role that interests you then please click respond through the LinkedIn apply function or send your resume over to J.Greavesjohnson@sciproglobal.com.
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Seniority level
Executive -
Employment type
Full-time -
Job function
Manufacturing, Project Management, and Management -
Industries
Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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