Director/Sr. Director - Process Development
Greater Boston Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Lead all process development activities (cell culture/banking/development, fermentation, protein purification, tech transfers)
- Oversee internal(in-house) and external vendors (domestic & international CDMOs)
- Work cross-functionally with CMC & Manufacturing leaders such as Analytical, Drug Product, QA/QC, Manufacturing, Supply Chain, etc.
- Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)
- Manage upstream and downstream scientist
Qualifications:
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience & prior management experience
- Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
- Experience overseeing outsourced vendors (CDMOs) and internal R&D activities
- Expert authoring and strategically working on IND/IMPD - BLA/MAA submissions
- Exposure to several modalities is highly sought after (mAbs, ADCs, fusion proteins, VLPs, & Vaccines)
