Scientist II, QC Analytical (2nd Shift) Columbus, Ohio

Forge Biologics Inc.; Columbus (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Paid parental leave

401(k) with company match

Onsite fitness facility

Job summary

Forge Biologics Inc. in Columbus, OH, is seeking a Scientist II, Quality Control to lead hands-on analytical testing and oversee QC staff. You will advance method development, validation, and troubleshooting for gene therapy products, ensuring testing aligns with cGMP, regulatory requirements, and internal SOPs.

The role emphasizes leadership, mentoring, and collaboration with PD, research, and GMP laboratories to drive quality improvements and support pre-clinical through commercial activities.

Qualifications

• Bachelor’s degree or international equivalent with 6+ years of relevant experience and demonstrated leadership.
• Advanced molecular biology/biochemistry techniques and analytical methods (qPCR, ELISA).
• Proven ability to coach and mentor direct reports.
• Strong data interpretation and quality improvement focus.
• Robust understanding of cGMP in QC and analytical testing.

Responsibilities

• Perform in-process, release, and stability testing for AAV-based products.
• Lead analytical QC assays (qPCR, ELISA, SDS-PAGE, Western blot, HPLC).
• Oversee SME activities to troubleshoot processes and transfer methods.
• Draft and review QC documents and specifications.
• Investigate OOS and CAPA actions with timely corrective actions.
• Support regulatory inspections and internal GMP audits.
• Provide mentorship and performance management for QC staff.

Skills

qPCR

ELISA

SDS-PAGE

Western blot

HPLC

Leadership

Mentoring

Coaching

cGMP knowledge

Data interpretation

Education

Bachelor’s degree

Master’s degree

PhD

Tools

EQMS

LIMS

Veeva

ADP

Job description

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.

About The Role

Scientist II, Quality Control: This role combines hands‑on analytical testing with leadership and oversight of QC staff. This position ensures that testing is performed according to cGMP, regulatory requirements, and internal SOPs, while also fostering team development, managing daily workflows, and supporting continuous improvement. This role will also be responsible for advancing method development, validation, and troubleshooting efforts for gene therapy products.

Responsibilities

Scientist Responsibilities:

• Perform in‑process, release, and stability testing for our most advanced AAV‑based (viral vector) therapeutic candidates generated from PD, research, and GMP laboratories.
• Lead and perform advanced analytical testing quality control assays, including qPCR, ELISA, SDS‑PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.
• Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay.
• Ensure the effective 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 reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
• Conduct thorough investigations to determine root cause of OOS investigations and other non‑conforming results and implement 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 and final product testing controls, including, but not limited to, Standard Operating Procedures (SOPs), Specifications, and Analytical Test Methods.
• Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
• Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
• Draft and revise process documents, assay methods, and sampling plans.
• Support regulatory and client inspections and support internal audits of GMP systems as an SME.

Manager Responsibilities:

• Provide technical guidance and mentorship to direct reports and junior team members, promoting their personal growth and skill development.
• Assist/trip 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.
• Responsible for performance appraisals and pay reviews of direct reports. Make decisions based on assigned objectives, as well as company policies and procedures.
• Participate in hiring process as assigned.
• Communicate updates proactively to Quality Control management and direct reports as needed.
• Perform review and approval (where appropriate) of laboratory data, methods, forms and investigations.
• Ensuring training for direct reports is driven to completion to support laboratory needs.

Qualifications

• Bachelor’s (or international equivalent) and/or 6+ years of relevant experience, Master’s, or PhD in a relevant scientific field (e.g., biology, biochemistry, molecular biology) with demonstrated leadership skills.
• Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, ELISA).
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• 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.

Preferred Skills

• SME in at least one of the following: Cell, Protein, or Nucleic Acid based assays.
• Ability to multi‑task.
• Effective communication with both management and direct reports.
• Prefer experience with software programs, including, but not limited to: Microsoft software, Veeva, ADP.
• Demonstrated ability to problem‑solve.

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.

Benefits

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.
• 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 career and grow within Forge.