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Associate Director, Downstream Process Development & MFG


Posted etwa 19 Stunden her

SciPro has partnered with a Boston Based Biotech that has nearly doubled their headcount in the last 6 months. My client has an impressive pipeline despite being founded a few years ago! Currently they have two phase III molecules in their pipeline, three phase II molecules, and an impressive preclinical pipeline. My client recently just got FDA approval for one of their leading candidates, thus making the hire even more business critical!

As an Associate Director, Downstream Process Development you will be reporting into the VP of TechOps, leaving significant growth opportunity. You will serve as the lead for the organizations most critical clinical programs and spearhead the organizations first BLA.

The major responsibilities of this role will be driving forward BLA enabling activities: Process Characterization, DOE, PPQ, Scale - Up, authoring BLA documentation, and managing external partners.

Preferred Skills:

  • PhD 5+ years of experience , M.S. 6-10 years of experience, and B.S. and 11+ years of experience

  • Candidate must have experience with large molecule Biologics

  • PPQ experience, Process Characterization, and Tech Transfer experience is required

  • BLA experience is a bonus***

  • Experience leading several programs at once

  • Excellent oral and written communication skills for effectively interfacing with all levels of management

  • Prior leadership experience of at least managing large matrix teams

  • Process Validation experience is highly preferred

  • Ability to identify and address issues proactively in a timely manner

  • Strong leadership capabilities and ability to work cross-functionally

  • Experience with preparing regulatory filings