QC RM Analyst II

About this role

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.

Summary:

We are currently seeking an Analyst I I , Quality Control (Raw Materials) to join the Forge Biologics team. In this role, you will be responsible for conducting testing and evaluation of raw materials used in AAV vector production. Your work will involve material sampling and executing various analytical tests per the processes defined within SOP documents in a cGMP compliant manner. Additionally, you will be responsible for performing comparisons between measured results and expected criteria and communicating those comparisons in a timely and thorough way. Your contribution will be essential in maintaining the integrity and safety of our gene therapy products.

Responsibilities:

• Inspect all materials that arrive at the facility for integrity and quality.

• Sample materials in a clean room environment

• Communicate between departments to ensure all operations have all required inspected materials.

• Perform routine testing and analysis of raw materials using established protocols and analytical methods.

• Conduct a range of tests, including but not limited to identity, purity, potency, and microbial contamination, on incoming raw materials.

• Accurately document test results, observations, and procedures in accordance with Good Documentation Practices (GDP).

• Collaborate with the procurement team to ensure timely receipt and testing of raw materials.

• Escalate any non-conformance or deviations to appropriate channels for investigation and resolution.

• Assist in the development and optimization of new testing methods and procedures.

• Contributes to the maintenance, calibration, and qualification of laboratory equipment.

• Supports the onboarding and training of team members in routine tasks and established procedures

• Adhere to Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements.

Qualifications:

• Associate’s or Bachelor’s Degree in Biology, Biochemistry, Chemistry or a related discipline.

• Familiarity with basic laboratory techniques and analytical methods.

• Ability to lift 50lbs

Preferred Qualifications:

• Prior experience in a laboratory or quality control environment.

• Sampling in a clean room environment

• Understanding of cGMP and regulatory guidelines.

Competencies:

• Attention to detail, accuracy, and the ability to follow protocols.

• Strong organizational and documentation skills.

• Effective communication and ability to work within a team.

• Willingness to learn and adapt to new techniques and technologies.

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. Must be able to lift, carry, push, and/or pull objects weighing up to 50 lbs. 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 famil

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