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

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 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 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 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.
• Takeresponsibilityforestablishingtesting timelines, execution, and monitoring thetestresultsfor
  
  Growth promotion,Bioburden,Microbial , Bubble point,Endotoxin, Sterility, pH, Osmolality, Biological Indicators,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,Bioburden Endotoxin,and Osmolality).
• Perform/Reviewof Laboratory investigations, Deviations, Change controls, CAPAs  a timely manner.
• Oversee timely 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 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 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…