Head of Manufacturing

Newlimit

South San Francisco, US

On-site

Who this role is best for

Aimed at mid-level biotech professionals with deep mRNA manufacturing expertise who thrive in hands-on leadership roles.

Best fit for

Experienced nucleic acid therapy manufacturing leads seeking to pioneer epigenetic reprogramming medicines.
— “Experience leading drug substance or drug product manufacturing for nucleic acid therapies”
Scientists comfortable balancing lab troubleshooting with CMO coordination responsibilities.
— “Get in the lab and help teach, troubleshoot, and unblock projects”
Technical leaders who have shepherded therapies through early clinical stages.
— “Experience supporting therapies through late preclinical and early clinical development”

Things to consider

Position requires managing both internal teams and external manufacturing partners.
— “Orchestrate contract manufacturing organizations, debug logistical issues”
Must have hands-on mRNA manufacturing expertise beyond theoretical knowledge.
— “Deep knowledge of mRNA drug substance manufacturing”

How to stand out

Document specific instances where you accelerated manufacturing timelines for novel therapies.
— “Own manufacturing timelines and deliverables for the world’s first reprogramming medicines”
Highlight regulatory filing experience, especially CMC section authorship.
— “History of owning the CMC section of regulatory filings”
Showcase team-building achievements in nucleic acid manufacturing environments.
— “Manage and recruit talented scientists and engineers in drug substance and drug product teams”

Pace · Fast PacedCollaboration · HighAutonomy · HighDecision Impact · TeamLevel · Senior

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

successful manufacturing campaigns
timely delivery of medicines

Typical background

manufacturingdrug substanceproduct chemistry

Skills & requirements

Required

ManufacturingDrug SubstanceProduct ChemistryControls

Preferred

Team ManagementRegulatory Compliance

Stack & domain

Mrna Drug Substance ManufacturingBiotechnologyAgingDisease

About the role

Original posting from Newlimit via Greenhouse

Company info
NewLimit is a biotechnology company working to radically extend human healthspan. We’re developing medicines to treat aging and age-related diseases by reprogramming the epigenome, a new therapeutic mechanism to restore regenerative potential in aged and diseased cells. We leverage functional genomics, pooled perturbation screening, and artificial intelligence systems to unravel the biology of aging and disease using experiments of unprecedented scale.
Description
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.
As part of the role you will:
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
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 have
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
Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO. Learn more at: https://www.newlimit.com/careers   
 

Source: Newlimit careers (Greenhouse)