Analytical Method Validation Jobs Near Me

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.
About the Role:
The Scientist I, Quality Control (Analytical) role will primarily focus on analytical method execution, method qualification, method validation, and troubleshooting efforts. This position will be responsible for executing in-process, final product, and stability testing for AAV vectors, plasmids, and microbial and mammalian cell banks, while ensuring that activities occur in an efficient and cGMP compliant manner. This role will function as a subject matter expert (SME) for either nucleic acid-based methods (e.g. ddPCR, qPCR), protein-based assays (e.g. CE, AUC), or cell-based assays (e.g. TCID50, potency). This position will also be responsible for fostering innovation within the QC department, either independently or by partnering with Analytical Development, ensuring cutting edge technologies are employed to maintain the highest QC standards in the analysis of gene therapy products. This role provides an opportunity to play a significant impact in the success of client gene therapy programs.
Responsibilities:

• Perform in-process, release, and stability testing for assays relevant to viral vector/gene therapy products, plasmids, and cell banks, including in-process testing, lot release testing, assay qualification, and validations.

• Function as an SME for either nucleic acid-based methods (e.g. ddPCR, qPCR), protein-based assays (e.g. CE, AUC), or cell-based assays (e.g. TCID50, potency). Additionally, perform advanced analytical testing quality control assays, including compendial testing, ELISA, and viability assays, to assess the quality, potency, and safety of AAV vector products.

• Support troubleshooting of processes/assays as an SME. Represent QC as a SME during audits and inspections.

• Ensure effective qualifications, validations, and transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.

• Contribute to authoring and/or reviewing QC documentation, including but not limited to: SOPs, analytical methods and forms, qualifications protocols, and validation protocols.

• Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.

• Provide support for Deviations, Change Controls, and CAPAs related to in process and final product testing.

• Review and approve GMP documentation associated with in process, final product, and stability testing.

• Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.

• Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.

• Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.

• Support regulatory and client inspections and internal audits of GMP systems.

• Manage tracking and trending of in process and final product testing data, including, but not limited to; leading/participating in out of specification (OOS)/out of trend (OOT) Laboratory Investigations.

Qualifications:

• Bachelor's, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology). Advanced degree preferred.

• SME for either nucleic acid-based methods (e.g. ddPCR, qPCR), protein-based assays (e.g. CE, AUC), or cell-based assays (e.g. TCID50, potency) based on experience. Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, cell-based infectivity assays, potency assays).

• Proven ability to execute, troubleshoot, and optimize analytical assays.

• Strong analytical and data interpretation skills to assess and drive quality improvement through the analysis of quality metrics and performance data.

• Robust understanding of cGMP requirements as they pertain to Quality Control and Analytical Development testing.

• Experience in leading, mentoring, and guiding junior team members.

• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.

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.