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.
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!