Senior Analyst, Quality Control (EM &Micro) 2nd Shift New Columbus, Ohio

Forge Biologics; Columbus (OH); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid parental leave

Annual bonus opportunities

Onsite fitness facility

Job summary

Forge Biologics in Columbus, Ohio is seeking a Senior Analyst, Quality Control (EM & Micro) on 2nd shift to lead EM testing and microbiology activities. The role emphasizes SME responsibilities, SOP development, and collaboration across QC and cross-functional teams.

The candidate will supervise testing, CAPAs, deviations and may mentor junior analysts while supporting regulatory inspections and internal audits. The environment offers growth, mentorship, and a commitment to patient impact.

Qualifications

• Bachelor’s degree in microbiology, biology or related field is required.
• Minimum 4 years of GMP-regulated QC or EM experience including Microbiology lab.
• Proficiency in microbiology techniques: Bioburden, Endotoxin, Sterility, Growth Promotion.
• Experience with Environmental Monitoring and clean room sampling.
• Familiarity with EMPQ protocols, risk assessments and CAPA processes.
• Experience drafting SOPs, change controls and lab investigations using Veeva Vault/TrackWise.

Responsibilities

• Serve as SME for EM and Microbiology testing and method enhancements.
• Manage testing timelines, execution, and results for growth promotion and sterility.
• Write and implement SOPs, work instructions, and QC protocols per cGMP.
• Oversee QC buffer testing and results entry into databases.
• Lead investigations, deviations, change controls, CAPAs timely.
• Mentor junior analysts and provide technical guidance.

Skills

EM testing

Microbiology

SOP writing

CAPA

GMP knowledge

Training/mentoring

Education

Bachelor’s degree in microbiology or related field

Tools

JMP

LIMS

NetSuite

Veeva Vault

TrackWise

Job description

Senior Analyst, Quality Control (EM &Micro)2nd Shift

Columbus, Ohio

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 ofH.O.P.E.We arehardworking, showing up each day with determination and grit. We areopen, creating a space where ideas flow freely, and every voice is valued. We arepurpose-driven, with every task directly tied to changing lives. And we areengaged, 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 EMtesting and Microbiology Lab testing and takes ownership of the different testing, collaborating of quality initiatives and inprovidingtechnical guidance to the junior staff. This role provides opportunities toutilizeexperience and implementnew technologiesin QC Microbiology.

Responsibilities:

• Serve as SME for EM and Microbiology testing in trouble shooting, enhancement to micro methods and EM sample management.
• Takeresponsibilityforestablishingtesting timelines, execution, and monitoring thetestresultsforGrowth promotion,Bioburden,Microbial ID, Bubble point,Endotoxin, Sterility, pH, Osmolality, BiologicalIndicators,etc.
• Assist with writing and implementing SOP’s, work instructions and protocols according to cGMPand Forge guidelines.
• Oversee scheduling, tracking and release of QC Buffer testing(pH,Conductivity,BioburdenEndotoxin,and Osmolality).
• Perform/ReviewofLaboratory investigations, Deviations, Change controls, CAPAs etc.in a timely manner.
• Overseetimely entryof 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, BBand Sterilityvalidationsand other validations activities.
• Work collaboratively withcrossfunctional teamsto improve quality, increase efficiencyand turnaroundof Micro/EM testing results.
• Performtraining andtechnical guidanceon laboratory methods and instrumentationto otherJuniorAnalysts.
• Support regulatory and clientinspections andsupport QCEM/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 aGMP-regulated QC or EM environment including Microbiology Laboratory.
• Demonstratedproficiencyin microbiology laboratory techniques such as Bioburden by membrane filtration/Milliflex,Endotoxin analysis,Sterilitytesting,Growth Promotion testing,biologicalindicators,Chemical Indicators,Filter integrity testing, Buffer Testingetc.
• Demonstrate proficiency and understandingof EnvironmentalMonitoring, 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, riskassessments,and final EMPQreports,etc.
• Demonstrated experience in performing Deviations and Lab investigations,Changecontrols, CAPAs and new document/SOP creation using Veeva Vault/Trackwise,and othersoftware (JMP, LIMS,NetSuitesetc.)
• Previous experience or demonstrated skills to lead/mentor a group of QC Analysts.

Preferred Skills:

• Experience leadingEMPQ andother EM projects.
• Experience insupervisingQC Microbiology lab testing.
• Experienced inInteractions withregulatory inspections or audits.
• Expertiserisk 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.

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 youand 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.
• 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.