Neogene Therapeutics
Pushing the Frontier by pioneering a new class of fully personalized T cell therapies to treat cancer
11 - 50
Manager Technical Writer, Regulatory Affairs - CMC
August 24
🏢 In-office - Los Angeles
Neogene Therapeutics
Pushing the Frontier by pioneering a new class of fully personalized T cell therapies to treat cancer
11 - 50
Description
• Responsible for CMC technical document review and writing • Author and compile CMC sections for global regulatory filings • Collaborate with cross-functional teams
Requirements
• BA/BS degree in life sciences required, advanced degree preferred (MS, PharmD). • Experience of 8+ years with BS/BA; 6+ years with MS/MA. • Prior experience in cell/gene therapy. • The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience. • The candidate must have CTD Module 3 authoring skills. • Experience in IND, IMPD, BLA, MAA filings.
Benefits
• Short-term incentive bonus opportunity • Equity-based long-term incentive program • 401(k) plan • Paid vacation and holidays; paid leaves • Health benefits including medical, prescription drug, dental, and vision coverage. • Equal Opportunity Employer
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