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
If this role aligns with your skillset and career goals, please apply below!