SciPro has recently partnered with a globally renowned pharmaceutical company’s Injectable Drug Product formulation team on a Senior Director of Injectable Product Development. This team is currently supporting rapid pipeline development with a diverse portfolio of modalities. This team offers all the benefits of a startup's team culture while also providing strong backing as a highly-ranked large pharma company.
Position Requirements:
Advanced degree with minimum 12 years of industry experience with a focus on parenteral drug product development
8-10 years of direct management experience
Experience leading IND/BLA submissions and responding to regulatory enquiries is required
Hands-on gene therapy / biologics experience
Experience in mid- to late-stages of drug development process (exposure to scale-up activities, PPQ planning and execution, risk analysis, etc.)
Experience leading a program from pre-IND to commercialization
Experience leading strategic initiatives for DP programs
What you’ll be doing:
Leading cross-functional CMC operations for the company’s injectable drug product operations
Supervising the late-stage development of the company’s pipeline
Mentoring junior colleagues for injectable development and tech transfer activities
Contributing extensively to IND/BLA filings and revisions
Working cross-functionally with DS/QC/QA/AD teams to troubleshoot product development
criteria and support CMC program development
Ensuring GMP compliance both internally and externally