Support & oversee analytical technology transfer & validation, & overall management of Chemistry, Manufacturing, & Control (CMC) activities related to external quality control (QC) testing/release & stability of antibody drug conjugates & intermediates. Contribute to management of analytical development & QC activities in Phase 1 through BLA & commercial production. Effectively manage Dyne's complex clinical supply chain & support eventual launch & commercialization efforts.
Requirements:
- Bachelor's (or higher) or equivalent in Biology, Biochemistry, Chemistry, Pharmaceutical Sciences, or closely related field
- 2 years in Analytical Development or Quality Control (QC) or R&D
- 2 years authoring regulatory filings & defending queries
- Up to 30% travel domestically (15%) and internationally (15%)
Application Instructions:
Resumes to: Ashley Clark, Director, HR, Job Code SVB-SMAD, Dyne Therapeutics, Inc., 1560 Trapelo Rd, Waltham, MA 02451.
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