---
title: 'Senior Analyst, Quality Control (EM &Micro) 2nd Shift at Forge Biologics'
canonical: 'https://feeny.ai/job/senior-analyst-quality-control-em-micro-2nd-shift-forge-biologics-columbus-ehejxbd69ccs'
type: 'job'
last_seen: '2026-09-10'
---

# Senior Analyst, Quality Control (EM &Micro) 2nd Shift at Forge Biologics

- **Company:** Forge Biologics
- **Location:** Columbus, OH
- **Posted:** 2026-08-26
- **Last confirmed live:** 2026-09-10
- **Apply:** https://boards.greenhouse.io/forgebiologics/jobs/6145631004?gh_jid=6145631004

## Job description

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.

If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

Position Overview:

Senior Analyst, Quality Control (EM &Micro) will serve as Subject Matter Expert (SME) for EM testing and Microbiology Lab testing and takes ownership of the different testing, collaborating of quality initiatives and in providing technical guidance to the junior staff. This role provides opportunities to utilize experience and implement new technologies in QC Microbiology.

Responsibilities:

- Serve as SME for EM and Microbiology testing in trouble shooting, enhancement to micro methods and EM sample management.
- Take responsibility for establishing testing timelines, execution, and monitoring the test results for Growth promotion, Bioburden, Microbial ID, Bubble point, Endotoxin, Sterility, pH, Osmolality, Biological Indicators, etc.
- Assist with writing and implementing SOP’s, work instructions and protocols according to cGMP and Forge guidelines.
- Oversee scheduling, tracking and release of QC Buffer testing (pH, Conductivity, Bioburden Endotoxin, and Osmolality).
- Perform / Review of Laboratory investigations, Deviations, Change controls, CAPAs etc. in a timely manner.
- Oversee timely entry of various testing results into databases and assist timely closure of EM trending reports.
- Submit purchase orders for equipment and materials-Inventory Management
- Assist with APS, hold time studies, BI studies, BB and Sterility validations and other validations activities.
- Work collaboratively with cross functional teams to improve quality, increase efficiency and turnaround of  Micro/EM testing results.
- Perform training and technical guidance on laboratory methods and instrumentation to other Junior Analysts.
- Support regulatory and client inspections and support QC EM/Micro in internal audits.
- Perform other duties as assigned

Qualifications:

- Bachelor’s degree in microbiology, Biology or related scientific field required.
- Minimum of 4 years of experience in a GMP-regulated QC or EM environment including Microbiology Laboratory.
- Demonstrated proficiency in microbiology laboratory techniques such as Bioburden by membrane filtration/Milliflex, Endotoxin analysis, Sterility testing, Growth Promotion testing, biological indicators, Chemical Indicators, Filter integrity testing, Buffer Testing etc.
- Demonstrate proficiency and understanding of Environmental Monitoring, Clean room sampling with air samplers (viable and non-viable), surface sampling.
- Experience in understanding/ implementing RMMs and other new methodologies ( eg; Sterility testing)
- Demonstrated experience in drafting EMPQ protocols, risk assessments, and final EMPQ reports, etc.
- Demonstrated experience in performing Deviations and Lab investigations, Change controls, CAPAs and new document/SOP creation using Veeva Vault/Trackwise, and other software (JMP, LIMS, NetSuites etc.)
- Previous experience or demonstrated skills to lead/mentor a group of QC Analysts.

Preferred Skills:

- Experience leading EMPQ and other EM projects.
- Experience in supervising QC Microbiology lab testing.
- Experienced in Interactions with regulatory inspections or audits.
- Expertise risk assessment tools and quality systems.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.

Work Environment and Physical Demands

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We’ve Got You Covered:

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Health from day one

- Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.

Time to recharge

- A competitive paid time off plan – because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact

- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.

## Your wellness, supported

- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.

Fuel for your workday

- A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.

Grow with us

- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

## About Forge Biologics

## Company Overview
- **One-liner**: Forge Biologics is a US-based gene therapy CDMO (Contract Development and Manufacturing Organization) that provides AAV-focused development, cGMP manufacturing, and analytical services to accelerate therapies from concept to commercial.
- **Entity Type**: Private (subsidiary of the Ajinomoto Group)
- **Headquarters**: Columbus, Ohio, USA
- **Founded**: Not publicly available
- **Founders**: Not publicly available – the company was founded by gene therapy developers, but specific names are not disclosed [forgebiologics.com](https://www.forgebiologics.com/about/)

## Core Business
- **Primary industry**: Gene therapy contract development and manufacturing (CDMO), with a singular focus on adeno-associated virus (AAV) vectors.
- **Target customers**: Gene therapy innovators, including researchers, biotechnology companies, and pharmaceutical developers (B2B, from early discovery through commercial production).
- **Mission**: “To enable access to life-changing gene therapies by helping bring them from concept to reality” [forgebiologics.com](https://www.forgebiologics.com/about/)

## Products & Services
- **[The Hearth]**: 200,000+ sq. ft. cGMP facility with 20 custom-designed cGMP suites, bioreactors ranging from 50 to 5,000L, and dedicated space for future expansion – one of the largest AAV manufacturing sites in the world. [forgebiologics.com](https://www.forgebiologics.com/facility/)
- **[FUEL™ Technology Platform]**: Includes novel technologies such as Ignition Cells™, pEMBR™ 2.0 Ad Helper, modified rep/caps, and advanced analytics for AAV characterization – designed to improve yield, speed, and quality. [forgebiologics.com](https://www.forgebiologics.com/)
- **Development & Manufacturing Services**: End-to-end support from molecular development, product-specific process development, IND review, analytical development, and cGMP manufacturing for clinical and commercial supply. [forgebiologics.com](https://www.forgebiologics.com/)
- **Quality & Regulatory Support**: A rigorous quality organization representing 30% of the team, divided into Quality Management (QA, systems, validation) and Quality Control (analytical, microbiology, environmental monitoring). [forgebiologics.com](https://www.forgebiologics.com/facility/)

## Market Standing
- **Valuation**: Not disclosed (private subsidiary of Ajinomoto Group)
- **Key Metric**: Total funding not applicable (subsidiary); however, over 60 clients have used Forge’s technologies, and more than 600 clients have been supported across all stages. The team numbers nearly 400 experts. [forgebiologics.com](https://www.forgebiologics.com/about/)
- **Notable Investors/Partners**: Parent company Ajinomoto Group (global scale); strategic partnerships with Skylark Bio and Epicrispr Biotechnologies. [forgebiologics.com](https://www.forgebiologics.com/)
- **Growth Signals**: 
  - My Green Lab® Certification earned in June 2026, highlighting sustainability leadership among global CDMOs. [forgebiologics.com](https://www.forgebiologics.com/)
  - Designation as a Gene and Cell Therapy Hub in Columbus, Ohio, leveraging regional gene therapy innovation legacy.
  - 35+ batches manufactured to date, with ongoing scale-up for larger programs and indications.
  - 20 cGMP suites and bioreactors up to 5,000L indicate growing capacity. [forgebiologics.com](https://www.forgebiologics.com/facility/)

## Competitive Advantages
- **Singular AAV focus**: Unlike multi-modal CDMOs, Forge is dedicated exclusively to AAV vectors, enabling deeper expertise, proprietary technology (FUEL™ platform), and optimized processes.
- **Purpose-built facility**: The Hearth is one of the largest AAV-dedicated cGMP manufacturing sites globally, with 20 suites and flexible bioreactor scales for seamless scale-up/down.
- **Quality-first culture**: 30% of the team is in Quality functions, ensuring rigorous compliance and reliability for clients.
- **Scientific & Manufacturing Advisory Board**: Independent industry leaders guide innovation and best practices. [forgebiologics.com](https://www.forgebiologics.com/company/leadership/)
- **Subsidiary of Ajinomoto Group**: Access to global scale, scientific legacy, and commercial infrastructure.

## Strategic Focus
- **Scaling capacity**: Continued expansion of The Hearth to accommodate more programs and larger indications, with space for additional cGMP suites.
- **Technology leadership**: Advancing the FUEL™ platform to improve AAV manufacturing yield, purity, and speed.
- **Sustainability**: Integration of green lab practices (My Green Lab certification) as a differentiator.
- **Talent development**: Annual internship program to cultivate next-generation gene therapy scientists. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Strategic partnerships**: Deepening collaborations with gene therapy developers (e.g., Skylark Bio, Epicrispr Biotechnologies) to support novel therapies.

## Why Work Here
- **Culture**: Driven by values of HOPE – hardworking, open, purpose-driven, and engage. Described as a diverse, passionate team redefining gene therapy manufacturing. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Work Environment**: Flexible work environment offered, plus an onsite fitness facility & wellness center. The Hearth is designed with social hubs for connection and recharge. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Benefits**: Medical, dental & vision insurance; generous PTO; 401K match; paid parental leave; Employee Assistance Program; bonus for every position. [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Recognition**: Forge has been named a “Best Place to Work” (recognition not further specified). [forgebiologics.com](https://www.forgebiologics.com/careers/)
- **Career Growth**: Nearly 400 employees; hands-on roles from science to operations; internship program for early talent. The company is growing rapidly.
- **Location**: Rooted in Columbus, Ohio – a region with strong gene therapy legacy, top talent, and ongoing investment. [forgebiologics.com](https://www.forgebiologics.com/facility/)
- **Job Listings**: Open roles posted on [Greenhouse](https://job-boards.greenhouse.io/forgebiologics) – candidates are cautioned against recruitment scams; Forge never asks for money or sensitive data during applications.

## Sources
1. [forgebiologics.com](https://www.forgebiologics.com/) – Main website with overview, mission, technology, and partnerships.
2. [forgebiologics.com/about/](https://www.forgebiologics.com/about/) – Company background, mission, leadership, values (HOPE), and team size.
3. [forgebiologics.com/facility/](https://www.forgebiologics.com/facility/) – The Hearth facility details (200k sq ft, 20 suites, bioreactor scales, quality organization).
4. [forgebiologics.com/careers/](https://www.forgebiologics.com/careers/) – Benefits, culture, internship program, and work environment.
5. [forgebiologics.com/company/leadership/](https://www.forgebiologics.com/company/leadership/) – Leadership team with advisory board.
6. [linkedin.com/company/forge-biologics](https://www.linkedin.com/company/forge-biologics) – LinkedIn company page for verification of size and industry.
7. [job-boards.greenhouse.io/forgebiologics](https://job-boards.greenhouse.io/forgebiologics) – Official career portal (Greenhouse) for current job openings.

## Other roles at Forge Biologics

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