Head of Manufacturing

NewLimit•South San Francisco, CA

About The Position

NewLimit is recruiting a Head of Manufacturing to lead drug substance and product chemistry, manufacturing, and controls (CMC). We are creating a new class of epigenetic reprogramming medicines for aging that build upon LNP and mRNA technology. Our initial assets are progressing through the complex manufacturing cascade that these modalities entail. In this role, you will orchestrate manufacturing for some of the first reprogramming medicines to enter human trials. You will serve as the company’s resident expert in manufacturing & controls, and manage a team of talented scientists & engineers to achieve your goals.

Requirements

Ph.D. in a natural science or engineering discipline (biology, chemistry; chemical engineering, industrial engineering) or B.S. and equivalent industry experience
Experience leading drug substance or drug product manufacturing for nucleic acid therapies
Experience supporting therapies through late preclinical and early clinical development
Deep knowledge of mRNA drug substance manufacturing

Nice To Haves

Experience managing a team of scientists or engineers
Experience running a regulatory compliant manufacturing process or facility (GLP/GMP)
Experience leading an LNP-mRNA therapy manufacturing campaign
History of owning the CMC section of regulatory filings

Responsibilities

Lead manufacturing campaigns for epigenetic reprogramming medicines spanning DNA, mRNA, and lipid nanoparticle manufacturing
Own manufacturing timelines and deliverables for the world’s first reprogramming medicines
Orchestrate contract manufacturing organizations, debug logistical issues, and keep timelines on track
Manage and recruit talented scientists and engineers in drug substance and drug product teams
Get in the lab and help teach, troubleshoot, and unblock projects