Backed by GV.
About the role
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
What they're looking for
- BA/BS degree in a scientific/engineering discipline with 15 + years experience, 10 of which in the biotech industry, Level will be commensurate with experience
- 9+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) with direct technical writing experience for IND/CTA/MF and BLA/MAA submissions
- Experience with cell and gene therapy and/or lipid nanoparticles is desirable
- Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines, with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products
- Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred
- Strong experience with CTD format and content regulatory filings
More about this role
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead regulatory activities...
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