Director, Quality Control - Raw Materials

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 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.

Summary:

We are seeking aDirector, Quality Control(Raw Materials)to join the Forge Biologics team. The Director of Quality Control (QC), Raw Materials (RM)will actively contribute to the strategic, operational, and laboratory activitiesrequiredto supportthe developmentand management of the raw material testing program. The Director manages the QCRaw Materialsdepartment andwill collaborate withinternalManufacturing, Supply Chain, Facilities,and QualitySenior Management, as well as externalsuppliers,toaddress quality-related issues.This role will also support continued development of phase-appropriate raw material qualification, laboratory readiness, external testing oversight, and inspection-ready quality systems to support pre-clinical, clinical, and commercial manufacturing activities.

Responsibilities:

• Provides strategic and operationalleadership toa Quality Control department responsible forraw material sample receipt, incoming inspection and testing, and release of all starting materials (raw materials, consumables, etc.).

• Providesstrategic leadership and guidance tothe organization to develop and implement a material qualification programin a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.

• Remains current onnew technologies, and regulatory requirements that may have an impact on the company's development, while ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) asappropriate.

• Accountable for ensuring adherence to strict regulatory requirements to ensure product quality.

• Contributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports,andjustification of specifications.

• Works directly with Leadership and Senior Management toensureprocess communications are occurringin a timely manner, and budget and timelines are being adhered to.

• Serve as aSubject matter expert(SME)for raw materials issues, providing technicalexpertisealigned with current GMPs and current industry best practices.

• Participates in theEngineeringeffort(i.e., CAPEX)to assure analytical equipment and supporting materials are in place and meet GMP requirements from design through procurement,installationand operational readiness, and associated required documentation.

• Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.

Qualifications:

• Bachelor'sdegree inChemistry,Biochemistry, Molecular Biology, or related discipline (Master's Degreeor PhD is preferred).

• 8+ years of experience in leadership, management, or supervisory roles, preferably within the Gene Therapy/Cell Therapy industry.

• Comprehensive experience with the analytical methods used for raw materials testing.

• Expert-level knowledge of raw material requirements described in global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.

• Workingknowledge of cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, and molecular biology techniques.

• Expert-level knowledge of CMC analytical and regulatory requirements.

• Expert-level knowledge of cGMP requirements as they pertain to QualityControlraw materialtesting.

• Demonstrated experience in departmental budgeting, CAPEX procurement, IQ/OQ, safety, and status reporting to Leadership and Senior Management.

• Ability to work independently and collaboratively, asrequired, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

• Ability topresenttoandinteract with Leadership and Senior Management.

• Ability to work hours necessary to support production and/or product transfer activities.

Preferred:

• Experience starting up, scaling, or managing multiple QC laboratories or testing groups, including release, stability, raw materials, primary packaging, printed materials, and in-process testing.

• Hands-on or leadership experience with analyticalinstrumentationtroubleshooting, laboratory equipment qualification, computerized laboratory systems, and implementation ofnew technologiesor laboratory workflows.

• Experience in high-level interactions with domestic and international Regulatory agencies.

• Experience building, managing, or improving QC raw material programs, GMP testing operations, laboratory readiness activities, or supplier/material qualification processes.

• Experience with laboratory quality systems, including OOS/OOT investigations, deviations, CAPAs, change controls, data integrity expectations, andinspectionreadiness activities.

• Experience working with external contract laboratories, outsourced testing, supplier quality issues, method alignment, or materialspecificationlifecycle management.

• ASQ certification, Lean/Six Sigma certification, or other relevantquality,laboratory, or operational excellence credential.

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 a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This islargely asedentary role; persons holding office positions aregenerally subjectto inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularlyoperatea computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.

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 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.

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.