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Associate Director, Upstream Process Development

Posted 28 days ago

  • Expiry Date: 19 April 2021

am currently working 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 a a number of pre-clinical molecules. 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, Upstream Process Development you will be reporting into the Director, Upstream Process Development. You will serve as the lead for the organizations most critical clinical programs. 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

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

  • BLA experience is a bonus***

  • Knowledge of and experience with production of recombinant proteins using mammalian cell lines

  • Strong Analytical and technical skills

  • 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 in preparing regulatory filings

  • Willingness to grow within an organization

If interested, please apply or get in touch!