---
title: 'Associate Director, QC Analytics at ElevateBio'
canonical: 'https://feeny.ai/job/associate-director-qc-analytics-elevatebio-waltham-7fnqhps6eqc9'
type: 'job'
last_seen: '2026-11-06'
---

# Associate Director, QC Analytics at ElevateBio

- **Company:** ElevateBio
- **Location:** Waltham, MA
- **Posted:** 2026-11-02
- **Last confirmed live:** 2026-11-06
- **Apply:** https://elevate.bio/about/jobs/6238584004?gh_jid=6238584004

## Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

## The Role

The Associate Director, QC Analytics provides operational leadership for routine GMP analytical testing at ElevateBio’s Waltham site and leads a team of managers responsible for seven-day laboratory operations. This role is accountable for predictable execution of product release and in-process testing, laboratory excellence, right-first-time performance, and timely, compliant reporting of results. The Associate Director leads the testing organization through disciplined capacity planning, daily management, schedule control, performance management, and rapid resolution of operational barriers across the full operating week. The role partners closely with Quality Control Analytical Technologies (QCAT), which provides technical enablement and analytical lifecycle leadership, to ensure new or changed methods, equipment, controls, critical reagents, and digital capabilities transition into stable, sustainable routine operations.

Here’s What You’ll Do

Release Testing Execution

- Own the integrated plan for routine release, in-process, characterization, and other assigned GMP testing; align capacity, staffing, instruments, and seven-day coverage to demand.
- Use tiered daily management and clear escalation to control sample readiness, analyst qualification, instrument availability, testing, review, and result reporting.
- Partner with Manufacturing to prioritize and rapidly execute STAT in-process samples within required decision windows; immediately escalate delays or risks.
- Partner with QC Logistics to align sample plans, receipt and chain of custody, contract laboratory dependencies, and stability pulls with testing schedules.

Laboratory Excellence

- Lead safe, compliant, inspection-ready laboratory operations with clear work allocation, standard work, trained personnel, and available equipment, reagents, and consumables.
- Drive right-first-time execution and reduce repeat work, documentation errors, queue time, and schedule variability through structured problem solving and continuous improvement.
- Monitor schedule adherence, turnaround time, right-first-time performance, repeat testing, investigation aging, review cycle time, capacity utilization, and backlog health.

QCAT Interface and Operational Readiness

- Partner with QCAT on method transfer, qualification and validation, equipment qualification, controls and critical reagents, lifecycle changes, and Digital QC initiatives.
- Define and confirm readiness for operational handoff, including approved methods and specifications, trained analysts, qualified equipment and systems, data workflows, troubleshooting guidance, materials, and sustainable capacity.
- Implement QCAT-enabled changes through controlled deployment and post-implementation monitoring, and provide routine-use data and feedback for lifecycle improvement.
- Maintain clear accountability: QCAT leads technical enablement and analytical lifecycle activities; QC Analytics owns routine execution and delivery after handoff.

Quality, Compliance, and Investigations

- Ensure testing, records, review, and reporting meet cGMP, approved procedures, specifications, quality agreements, data-integrity expectations, and program commitments.
- Lead operational response to laboratory events, deviations, atypical or out-of-specification results, CAPAs, change controls, and risks; partner with QCAT and Quality Assurance when technical lifecycle expertise is required.
- Represent QC Analytics during audits, inspections, governance meetings, release-readiness reviews, and operational escalations.

People and Organizational Leadership

- Lead and develop a team of managers responsible for seven-day laboratory operations and the broader testing organization, with clear objectives, decision rights, coverage expectations, and accountability.
- Build qualification, cross-training, succession, resource, and capability plans that support demand and reduce single points of failure.
- Create an inclusive, high-accountability culture grounded in safety, quality ownership, transparent communication, and continuous learning.

## Requirements

- Bachelor’s degree in Biology, Biochemistry, Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline; an advanced degree is preferred.
- At least 10 years of relevant experience in a GMP Quality Control or analytical laboratory environment, including progressive people and operational leadership responsibility.
- Demonstrated leadership of routine GMP testing supporting product release in biotechnology, pharmaceutical, biologics, cell therapy, gene therapy, or another regulated environment.
- Demonstrated ability to improve schedule reliability, laboratory flow, right-first-time performance, and capacity utilization through daily management, standard work, metrics, and structured problem solving.
- Strong working knowledge of cGMP laboratory controls, data integrity, method execution, specifications, laboratory investigations, deviations, CAPAs, change control, and inspection readiness.
- Experience with analytical technologies relevant to advanced therapies, such as molecular methods, flow cytometry, immunoassays, chromatography, and cell-based assays, is preferred.
- Experience operating at the interface between routine testing and analytical lifecycle or technical teams, including method transfer, qualification, validation, equipment qualification, and digital laboratory implementation.
- Experience with laboratory systems such as LIMS, CDS, ELN, SDMS, QMS, CMMS, ERP, or related platforms.
- Strong capacity-planning, prioritization, risk-management, communication, and stakeholder-management skills in a multi-program or CDMO environment.
- Proven ability to develop leaders and teams, manage competing priorities, make timely decisions, and communicate clearly with clients, technical partners, Quality Assurance, Manufacturing, and senior leadership.

Physical and Environment Requirements:

- Ability to stand, walk, bend and stretch for extended period of time
- Ability to lift 15-20 lbs
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
- Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $165,000 - $225,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

## About ElevateBio

## Company Overview
- **One-liner**: ElevateBio is a technology-driven contract development and manufacturing organization (CDMO) that powers the creation of genetic medicines by providing integrated gene editing, process development, and cGMP manufacturing capabilities.
- **Entity Type**: Private (Series D – raised $401M in November 2025; total capital raised ~$1.3B)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: 2017
- **Founders**: Not publicly available

## Core Business
- Primary industry: Biopharmaceutical CDMO (cell and gene therapy, gene editing, mRNA therapeutics)
- Target customers: Biopharmaceutical innovators (B2B, enterprise)
- Mission: “To be the world’s most indispensable advanced therapy technology company, changing how companies operate, how products are created, and how disease is treated.”

## Products & Services
- **Gene Editing Tools & Discovery Services**: One of the world’s largest toolboxes of gene editing technologies (e.g., CRISPR enzymes), enabling flexible editing and broad access to the genome. Includes discovery services to move from target to optimized therapeutic candidate.
- **Process Development**: Scalable, robust manufacturing process design from preclinical through commercial scale.
- **Manufacturing (cGMP)**: Viral vectors, cell therapies, mRNA therapeutics, and lipid nanoparticles (LNP). Multi-modality capabilities with 98% batch success rate. Automated cell therapy manufacturing platform.
- **Regulatory Support & Commercialization**: Navigate CMC regulatory strategy from IND through BLA.
- **Next-Generation Sequencing / Rapid Analytics**: In-house analytics for quality and characterization.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private company)
- **Key Metric**: Total funding ~$1.3 billion (as of Series D close in November 2025)
- **Notable Investors/Partners**: Novo Nordisk (multi-target R&D collaboration worth up to ~$1.9B), Amazon Web Services (generative AI for CRISPR discovery), Sartorius (automated cell therapy platform), University of Pittsburgh / Richard King Mellon Foundation ($100M grant for biomanufacturing facility)
- **Growth Signals**: CNBC Disruptor 50 in 2021, 2023, 2024, 2025; Fast Company’s 2024 Most Innovative Companies; Boston Globe Top Place to Work (2022, 2023); first genetic medicines manufacturer to achieve ICMC multi-modality certification; opened flagship purpose-built biomanufacturing facility in Waltham, MA; achieved 98% manufacturing batch success rate across cell therapy, viral vector, and mRNA batches.

## Competitive Advantages
- **Integrated Model**: Science, process development, manufacturing, and quality operate under one roof – no hand-offs between stages.
- **Continuous Technology Investment**: Automation, AI-assisted design, and process innovation embedded as a permanent operating principle to reduce costs and timelines.
- **Multi-Modality Expertise**: Covers viral vectors, cell therapies, mRNA, LNP delivery, and gene editing – enabling partners to switch modalities without restarting.
- **Proprietary Gene Editing Toolbox**: Acquired Life Edit Therapeutics, adding one of the largest collections of gene editing enzymes and patents.
- **Industry-Leading Quality**: ICMC certification across multiple modalities and 98% batch success rate exceed industry standards.

## Strategic Focus
- Expand gene editing capabilities and delivery technologies (e.g., LNP in vivo delivery for nuclease editing).
- Scale manufacturing capacity through new facilities (Waltham flagship, Pittsburgh site).
- Deepen collaborations with pharma (Novo Nordisk) and tech (AWS) to accelerate therapy development.
- Apply generative AI to broaden CRISPR discovery for complex monogenic and polygenic diseases.
- Establish manufacturing blueprints for novel modalities such as base-edited therapies.

## Why Work Here
- **Culture**: Described as a group of “explorers” passionate about constant discovery, new technology, and progress in life-transforming therapies.
- **Benefits**: Medical, vision, and dental covered at 90%; low deductible; employer-paid life insurance and disability; 401(k) with 4% match (no vesting); 12 weeks parental leave; competitive PTO; commuter reimbursement; monthly cell phone stipend; fitness reimbursement; access to wellness apps.
- **Development**: LinkedIn Learning access, Insights Discovery training, ongoing professional development and manager training.
- **Work Environment**: Roles primarily based in Waltham, MA (on-site for manufacturing and lab positions). Hybrid/remote not explicitly stated but likely limited for operational roles.
- **Recognition**: Boston Globe Top Place to Work; named to CNBC Disruptor 50 multiple years.

## Sources
1. [elevate.bio](https://elevate.bio/)
2. [elevate.bio/about](https://elevate.bio/about/)
3. [elevate.bio/about/careers](https://elevate.bio/about/careers/)
4. [elevate.bio/about/our-journey](https://elevate.bio/about/our-journey/)
5. [LinkedIn](https://www.linkedin.com/company/elevatebio)

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