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Director / Sr. Director - Process Development CMC
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$210,000 - $240,000 a year
- Director/Sr. Director - Process DevelopmentGreater Boston Area Competitive Compensation + excellent bonus/benefitsDuties 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 scientistQualifications:M.S or Ph. D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience & prior management experienceExperience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc.)
- Experience overseeing outsourced vendors (CDMOs) and internal R&D activitiesExpert authoring and strategically working on IND/IMPD - BLA/MAA submissionsExposure to several modalities is highly sought after (mAbs, ADCs, fusion proteins, VLPs, & Vaccines)
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