We are in need of an expert Director/Sr. Director - Process Development CMC to join our cohesive team at EPM Scientific in Boston, MA.
Growing your career as a Full-Time Director/Sr. Director - Process Development CMC is an unparalleled opportunity to develop relevant skills.
If you are strong in people management, analysis and have the right commitment for the job, then apply for the position of Director/Sr. Director - Process Development CMC at EPM Scientific today!
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)
Benefits of working as a Director/Sr. Director - Process Development CMC in Boston, MA:
● Excellent benefits
● Advancement opportunities
● Competitive salary
No CV Required
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