Scientist II, QC Analytical (2nd Shift)

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

Benefits offered by this job

Health insurance

401(k) with company match

Onsite fitness facility

Mental health counseling

Job summary

Forge Biologics seeks a Scientist II, Quality Control, to lead hands-on analytical testing and oversight of QC staff at our Columbus facility. You will ensure testing adheres to cGMP, regulatory requirements, and SOPs while advancing method development and troubleshooting.

You will oversee method transfer, data analysis, and documentation, contributing to continuous improvement and regulatory readiness across pre-clinical to commercial programs.

Qualifications

• Bachelor's (or international equivalent) and/or 6+ years of relevant experience in a scientific field.
• Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, ELISA).
• Demonstrated leadership ability and experience managing direct reports.
• Proven ability to execute, troubleshoot, and optimize analytical assays.
• Strong analytical and data interpretation skills.
• Robust understanding of cGMP requirements as they pertain to Quality Control and Analytical Development testing.
• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.
• SME in at least one: Cell, Protein, or Nucleic Acid assays.
• Able to multitask and communicate effectively.
• Experience with software programs: Microsoft, Veeva, ADP.

Responsibilities

• Perform in-process, release, and stability testing for AAV-based therapeutic candidates from PD, research, and GMP labs.
• Lead and perform advanced QC assays (qPCR, ELISA, SDS-PAGE, Western blot, HPLC) to assess quality, potency, and safety of vector products.
• Support internal process transfer activities and serve as SME to troubleshoot processes/assays.
• Ensure effective transfer of analytical methods to QC across pre-clinical, clinical, and commercial activities.
• Contribute to authoring/reviewing QC reports, SOPs, QC protocols, and comparability reports.
• Conduct root-cause determinations for OOS investigations and implement CAPAs promptly.
• Provide support for Deviations, Change Controls, and CAPAs in testing.
• Review and approve GMP documentation for in-process and final product testing.
• Drive development, optimization, and validation of novel analytical methods.
• Compile data, generate reports, and archive assay data; interpret results.
• Draft/revise process documents and sampling plans.
• Support regulatory/client inspections and internal audits as SME.

Skills

Leadership

qPCR

ELISA

Molecular biology

Biochemistry

Data analysis

Communication

Education

Bachelor's degree or higher in relevant field

Master's or PhD preferred

Tools

LIMS

EQMS

GMP

qPCR instruments

SDS-PAGE

HPLC

Western blot

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 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.

About The Role:

Scientist II, Quality Control:This role combines hands-on analytical testing with leadership and oversight of QC staff. This positionwill ensure 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 alsobe responsible foradvancing method development, validation, and troubleshooting efforts for gene therapy products.

Responsibilities:

ScientistIIResponsibilities:

• 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 commercialactivities.
• Contribute to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification ofspecifications.
• Conducts thorough investigations todetermineroot cause of OOS investigations and other non-conforming results and implementsappropriate correctiveand preventative actions ina timelymanner.
• Provide support for Deviations, Change Controls, and CAPAs relatedto inprocess 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 clientinspections andsupport internal audits of GMP systemsas anSME.

ManagerResponsibilities:

• Provide technical guidance and mentorship to direct reports and junior team members, promoting their personal growth and skill development.
• Assist/drivetracking and trending of in-process and final product testing data, including, but not limited to; leading/participatingin out of specification (OOS)/out of trend (OOT) Laboratory Investigations.
• Responsible for performance appraisals and pay reviewsof direct reports. Make decisions based on assignedobjectives, as well as company policies and procedures.
• Participate inhiringprocess as assigned.
• Communicate updates proactively to Quality Control management and direct reports as needed.
• Perform review andapproval (whereappropriate)of laboratory data, methods,formsand investigations.
• Ensuringtraining fordirect 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 or 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 solv e .

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 andtypicaloffice 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 toidentifysmall detailswithin the field of vision, distinguish betweendifferent colors, and accuratelyidentifyobjects 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.

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

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 youandyour 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.