Director of Drug Product Manufacturing
Company: VirtualVocations
Location: Fremont
Posted on: October 31, 2024
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Job Description:
A company is looking for a Director, Drug Product Manufacturing
responsible for biologics drug product development and
manufacturing.
Key Responsibilities:
Lead biologics drug product technical development throughout the
program's lifecycle
Oversee technical transfer to CMOs and manage external drug product
development capabilities
Ensure compliance with FDA, cGMPs, and ICH guidelines while
authoring regulatory filings
Required Qualifications:
Ph.D. or Master's degree in Pharmaceutical Sciences, Chemical
Engineering, or relevant field
Minimum 10+ years of experience in biotech/pharma, focusing on drug
product development for therapeutic proteins
Extensive knowledge of protein formulation development and
fill-finish process engineering
Experience in generating CMC regulatory sections for IND, IMPD,
BLA, and MAA filings
Proven ability to manage global external vendors for development
and manufacturing
Keywords: VirtualVocations, Fremont , Director of Drug Product Manufacturing, Executive , Fremont, California
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