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 (Statistics) supports the application of statistical methods to bioanalytical assay development, qualification, and validation activities within the Quality Control and Analytical Development functions. This role applies established statistical approaches to ensure data integrity, regulatory compliance, and accurate interpretation of analytical results. The Scientist I collaborates cross-functionally to support experimental design, data analysis, and documentation, contributing to the advancement of gene therapy programs.

What You'll Do:

· Apply established statistical methods to support development, qualification, and validation of bioanalytical methods (e.g., potency assays, ddPCR workflows)

· Perform statistical analyses for assay validation, including linearity, accuracy, precision, and detection limits

· Support stability studies through trend analysis, control charting, and regression modeling

· Assist in data review, interpretation, and troubleshooting for assay development and optimization activities

· Contribute to statistical analysis plans (SAPs), validation protocols, technical reports, and regulatory documentation

· Collaborate with cross-functional teams (QC, Analytical Development, Process Development, Regulatory)

· Support investigations, deviations, and root cause analyses with statistical input

· Assist in developing and maintaining data trending and reporting tools

· Ensure compliance with regulatory requirements (e.g., ICH, USP, FDA)

· Communicate statistical findings clearly to stakeholders

What You'll Bring:

• Ph.D. in Statistics or related field (or Master’s with relevant experience)

• 1–3 years of relevant experience in a biopharmaceutical, biotechnology, or analytical laboratory setting

• Experience with statistical software (JMP, SAS, R, Python)

• Strong analytical and problem-solving skills

• Effective written and verbal communication skills

• Ability to work independently within defined frameworks and collaborate across teams

Preferred Skills

• Familiarity with nucleic acid-based assays (e.g., ddPCR, qPCR)

• Experience with protein or cell-based assays (e.g., ELISA, flow cytometry)

• Experience in GxP-regulated environments

• Exposure to assay validation and stability studies

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 is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.

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.

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:   

As an Associate Scientist II, you will play a key role in developing, optimizing, and supporting gene therapy manufacturing processes within the Manufacturing Science and Technology (MS&T) department. This multidisciplinary position partners closely with process development, manufacturing, quality, validation, facilities and engineering, and regulatory teams to ensure upstream, downstream, fill‑finish, buffer preparation, and support‑function processes are scalable, robust, and aligned with regulatory expectations. In this role, you will execute moderately complex, recurring assignments using established procedures, applying sound judgment to resolve straightforward issues and escalating exceptions when needed. You will help identify minor process gaps, contribute to continuous improvement efforts, and strengthen overall operational reliability. Through this work, you will support day‑to‑day operational excellence, enhance cross‑functional readiness, and contribute meaningfully to the organization’s broader success. 

Responsibilities: 

• Execute technology transfer activities from Process Development or clients into GMP Manufacturing, including defining critical quality attributes, key process parameters, and conditions essential for compliant manufacturing under cGMPs. 

• Serve as a technical contributor during technology transfer by reviewing client and Process Development processes and generating required transfer documentation. 

• Support the development, review, and maintenance of key documentation such as manufacturing batch records, production plans, bills of materials and SOPs. 

• Perform process monitoring by collecting, analyzing, and summarizing manufacturing data; prepare and present campaign summaries and related reports. 

• Support GMP execution of new processes and act as a Subject Matter Expert (SME) for change controls, deviation investigations, and CAPAs. 

• Track progress of routine manufacturing and technology transfer activities, provide timely updates, and proactively identify operational risks and mitigation strategies. 

• Build strong working relationships with internal teams and external clients, communicating responsibilities, expectations, and technical information clearly and respectfully to ensure GMP readiness and provide technical support throughout production campaigns. 

• Identify opportunities for process optimization and efficiency improvements across platform manufacturing processes and contribute to discussions on continuous improvement. 

Qualifications: 

• Bachelor’s degree in a relevant scientific discipline with 2+ years of directly related industry experience 

• Behaves ethically and in alignment with organizational values, showing strong communication, organizational, interpersonal, and emerging problem‑solving skills 

• Demonstrates sound judgment when working within clearly defined boundaries and seeks guidance appropriately 

• Collaborates effectively by assisting teammates, completing assigned tasks, and contributing constructively to group discussions 

Preferred Skills: 

• Experience working with viral vectors (AAV, Lentivirus, etc.). 

• Proven track record in supporting tech transfers. 

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   

The work environment is fast paced.  This position has the utmost responsibility for comprehending biologics manufacturing compliance with procedures and regulations regarding a safe and collaborative work environment relative to actions and conduct.  

This position works in a typical office environment where the physical demand varies depending on the specific tasks and duties assigned. The employee may be stationary (standing/sitting) for extended periods of time. The employee will be made aware and acknowledge established procedures regarding personal protective equipment and safety requirements specific to the company. Must be able to work in office space and trained & qualified to enter a production suite(s) or laboratory environment for general understanding of the business. 

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.