---
title: 'Manager/Senior Manager, CMC Quality Control at Lexeo Therapeutics'
canonical: 'https://feeny.ai/job/manager-senior-manager-cmc-quality-control-lexeo-therapeutics-new-york-ak1xnmwz3p3y'
type: 'job'
last_seen: '2026-10-19'
---

# Manager/Senior Manager, CMC Quality Control at Lexeo Therapeutics

- **Company:** Lexeo Therapeutics
- **Location:** New York, NY
- **Compensation:** $93k–$154k
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-09-15
- **Last confirmed live:** 2026-10-19
- **Apply:** https://jobs.lever.co/lexeotx/ee291176-9b9f-4cd2-8122-a30771c65705

## Job description

## Role Summary

The Manager/Senior Manager, CMC Quality Control (QC) is responsible for providing strategic and operational oversight of QC activities supporting Lexeo's gene therapy programs. This role serves as a QC lead for external contract testing laboratories (CTLs), analytical lifecycle management (i.e., late-phase method validation), stability programs, release testing support, and analytical investigation activities. The individual will work closely with Analytical Development, Technical Operations, Regulatory Affairs, Quality Assurance, and external partners to ensure analytical methods, specifications, and testing programs support clinical development, process validation readiness, and future commercial requirements. This position requires technical expertise in analytical testing, preferably of AAV-based products, as well as demonstrated experience overseeing external laboratories and driving cross-functional CMC initiatives.

Primary Responsibilities

- Lead QC oversight of external contract testing laboratories supporting release, characterization, validation, comparability, and stability testing activities
- Support product specification lifecycle management, including establishment, justification, trending, revision, and regulatory impact assessment
- Partner with Analytical Development and Technical Operations to support method qualification, validation, transfer, verification, and continued performance monitoring across testing laboratories
- Serve as QC subject matter expert for laboratory investigations, including OOS, OOT, atypical results, assay failures, and method performance events
- Support reference standard qualification, lifecycle management, and analytical comparability initiatives
- Provide technical oversight for method transfers, comparability assessments, and laboratory readiness
- Collaborate with Regulatory Affairs and CMC teams to author and review regulatory submissions, responses to health authority inquiries, technical reports, and analytical sections of INDs, BLAs, and other global filings
- Prepare and manage sample submission paperwork for external contract testing labs (CTLs), including quotes, purchase orders, shipping documents
- Coordinate shipment of samples, reference standards, and reagents to and from manufacturing sites, external vendors, and CTLs in compliance with storage and shipping requirements
- Collaborate with cross-functional CMC teams to align on sample submission and testing needs

Required Skills and Qualifications

- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biotechnology); advanced degree (MS) a plus
- 6+ years of experience  or 4+ with Master’s (Sr. Manager level: BS with 8+ years or MS with 6+ years experience) in Quality Control, Analytical Development, Manufacturing Sciences, Quality Assurance, or related CMC functions within biotechnology or pharmaceutical organizations
- Experience supporting late-stage development, process validation, and/or commercial readiness activities preferred
- Experience supporting biologics, cell therapy, gene therapy, or other advanced therapeutics preferred
- Strong understanding of cGMP regulations and global regulatory expectations applicable to analytical testing and Quality Control
- Experience with analytical method lifecycle management, including qualification, validation, transfer, verification, and continued performance monitoring
- Knowledge of analytical techniques commonly used for AAV and biologic products (i.e., ddPCR, cell-based potency, ELISA/immunoassays, residual impurities, compendial safety testing)
- Strong understanding of analytical control strategy development and specification management

## About LEXEO

Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease, including LX2006 for Friedreich ataxia (FA), LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need. Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home. LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.

## About Lexeo Therapeutics

## Company Overview
- **One-liner**: Lexeo Therapeutics is a clinical-stage genetic medicine company pioneering gene therapies to treat the root causes of inherited cardiovascular diseases and APOE4-associated Alzheimer’s disease.
- **Entity Type**: Public (NYSE: LXEO) – IPO in 2023
- **Headquarters**: New York, New York, United States (345 Park Avenue South, Floor 6)
- **Founded**: 2018
- **Founders**: Ronald Crystal, MD (Founder & Chief Scientific Adviser)

## Core Business
- **Primary industry/industries**: Biotechnology / Genetic Medicine / Gene Therapy
- **Target customers**: B2B (healthcare providers, clinical research institutions, patients via healthcare systems) – focus on larger-rare and prevalent cardiovascular indications with high unmet need.
- **Mission or purpose statement**: “Reshaping heart health by applying pioneering science to fundamentally change how cardiovascular diseases are treated” (from 10-K) – also “going beyond treating the symptoms of genetic disease by trying to stop its progress at its underlying cause” (from careers page).

## Products & Services
- **LX2006**: Gene therapy candidate for cardiomyopathy associated with Friedreich’s Ataxia (FA). Currently in Phase 1/2 SUNRISE-FA trial; positive interim data reported in 2025/2026. Plans to initiate a registrational study (SUNRISE-FA 2) in H1 2026.
- **LX2020**: Gene therapy candidate for arrhythmogenic cardiomyopathy (ACM) caused by PKP2 mutations. In Phase 1/2 HEROIC-PKP2 trial; positive interim data announced January 2026.
- **Preclinical pipeline**: Additional programs targeting hypertrophic cardiomyopathy, APOE4-associated Alzheimer’s disease, and other genetically defined conditions.

## Market Standing
- **Valuation/Market Cap**: $329.6 million (as of recent data from LinkedIn, 2026)
- **Key Metric**: Annual revenue of $654K (pre-commercial, clinical-stage); total funding not directly disclosed but backed by IPO and institutional investors.
- **Notable Investors/Partners**: Partnerships with Weill Cornell Medicine and University of California San Diego; institutional investors include those common in biotech IPOs (specific names not listed in provided sources).
- **Growth Signals**: 
  - Headcount grew 18.5% YoY to 81 employees (LinkedIn).
  - Positive interim clinical data for both lead programs.
  - FDA feedback expected Q2 2026 for registrational trial design.
  - Expanded pipeline into AI/Data Science for drug discovery (new Sr. Director role posted).

## Competitive Advantages
- **AAVrh10 vector technology**: High transduction efficiency in myocardial cells, lower toxicity potential, and low pre-existing immunity compared to other AAV serotypes.
- **Focus on larger-rare cardiovascular diseases**: Targeting conditions with high unmet need and no approved treatments, enabling a stepwise, capital-efficient development approach.
- **Strong academic partnerships**: Groundbreaking research from Weill Cornell and UCSD provides foundational science and credibility.
- **Full ownership**: Retains exclusive worldwide development and commercialization rights to all product candidates.

## Strategic Focus
- **Late-stage clinical advancement**: Pushing LX2006 and LX2020 toward registrational trials and potential BLA submission.
- **AI and data science integration**: Hiring a Senior Director of AI and Data Science to accelerate decision-making across discovery, development, and operations.
- **Expanding pipeline**: Leveraging early proof-of-concept data to address larger-rare and prevalent indications beyond current lead programs.
- **Manufacturing and CMC**: Scaling up AAV manufacturing processes using Sf9/baculovirus and HEK-based systems.

## Why Work Here
- **Culture**: “Passion to change the arc of medicine” – a mission-driven environment focused on transformative gene therapies.
- **Work model**: Hybrid – 2 days/week in the New York City office, 3 days remote (from careers page).
- **Compensation & benefits**:
  - Competitive salaries (e.g., Director/Sr. Director Clinical Development: $247,500 – $382,000/year)
  - Health, dental, vision, mental health benefits
  - 401(K) with company match, performance bonus, company equity
  - Unlimited PTO, paid holidays, paid parental leave
  - Commuter benefits, tech stipend, stocked kitchen, in-office lunch stipend
  - Life and disability insurance
- **Team**: Led by pioneers in gene therapy and rare disease drug development; small but growing company (81 employees) offering high impact and cross-functional ownership.
- **EEO**: Committed to an exciting, diverse, and enriching work environment.

## Sources
1. [sec.gov](https://www.sec.gov/Archives/edgar/data/1907108/000119312526193939/ars_10-k_2025.pdf) – Form 10-K for FY2025 (filed March 2026)
2. [linkedin.com](https://linkedin.com/company/lexeo-therapeutics) – LinkedIn company page (employees, revenue, market cap)
3. [lexeotx.com](https://www.lexeotx.com/careers/) – Careers page (benefits, culture, hybrid policy, job postings)
4. [jobs.lever.co](https://jobs.lever.co/lexeotx) – Lever job board (open positions)
5. [lexeotx.com](https://www.lexeotx.com/team/) – Leadership team page (founder, executives)

## Other roles at Lexeo Therapeutics

- [Research Associate I/II, Preclinical Research (Contract)](https://feeny.ai/job/research-associate-i-ii-preclinical-research-contract-lexeo-therapeutics-new-5cprbry5kqq2) — New York, NY
- [Scientist II, Cellular Neuroscience and Translational Pharmacology](https://feeny.ai/job/scientist-ii-cellular-neuroscience-and-translational-pharmacology-lexeo-b4597dp1w5gp) — New York, NY
- [Director/Senior Director, Clinical Development](https://feeny.ai/job/director-senior-director-clinical-development-lexeo-therapeutics-new-york-vkywdkr3hqn8) — New York, NY