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 LIMS System & Data Specialist II role will be the primary business user for the Veeva Laboratory Information Management System (LIMS) within the Quality Control (QC) group. This role is responsible for building and maintaining test definitions, sample plans, specification requirements and study designs in LIMS to support in-process, release, and stability testing for AAV, plasmid, cell bank, buffer, and raw materials, along with generation of electronic Certificate of Analysis (COA) and Certificate of Testing (COT) documents needed to support batch release or disposition. Acting as a Tier 1 LIMS support resource, this role partners closely with QC subject matter experts, QA, IT, and the LIMS System Administrator to support compliant system use, continuous improvement, and adoption of new LIMS functionality. This position plays a critical role in maintaining data integrity, operational readiness, and inspection preparedness in support of client gene therapy programs.

Responsibilities:

• Provide Tier 1 LIMS support
• Build and maintain test definitions, sampling plans, specifications, and stability protocols in Veeva LIMS, in collaboration with QC SMEs.
• Configure and issue Certificates of Analysis (COA) and Certificates of Testing (COT) in support of batch release and disposition.
• Support routine troubleshooting of data-related issues and escalate technical problems to System Admin or vendor as needed.
• Work with System Administrator to develop user requirements and test scripts for custom scripts, code, or automation tools to support LIMS integration with analytical instruments and other enterprise systems.
• Work closely with IT, QA, and QC leadership to test system settings, user roles, and permissions.
• Collaborate with laboratory staff to identify system improvements and customize LIMS functionalities.
• Develop SOPs, training materials, and documentation for LIMS system use and best practices.
• Train QC personnel on LIMS functionalities, data entry procedures, and reporting workflows.
• Ensure LIMS operations comply with GMP, FDA 21 CFR Part 11, USP, and data integrity requirements.
• Support internal and external regulatory audits and inspections by providing LIMS documentation and system access as required.
• Collaborate on periodic system reviews and validations to maintain compliance with regulatory standards.
• Work with QC leadership to support ongoing LIMS improvements and upgrades.
• Assist in integrating LIMS with other business systems and instruments.
• Assist with generating routine QC reports and trending data as requested.

Qualifications:

• AS or BS in Life Sciences, Biotechnology, or a related field is preferred, with degrees in Computer Science or a related field (or equivalent professional experience).
• Experience working in a GxP-regulated laboratory environment (biologics, gene therapy, or pharmaceuticals preferred).
• Familiarity with Veeva LIMS or other enterprise LIMS platforms (LabWare, LabVantage, STARLIMS, etc.).
• Experience working in compliance with FDA 21 CFR Part 11, GMP, and data integrity regulations.
• Strong problem-solving and analytical skills with attention to detail.
• Excellent communication and training abilities to support QC personnel.
• Strong collaboration with cross-functional teams (QC, QA, IT, Manufacturing, Regulatory Affairs, and external vendors).
• Ability to work onsite (in Columbus, Ohio) 2-3 days/week on average.

Preferred Skills:

• Understanding of QC analytical methods, sample types, and AAV manufacturing processes, or viral vector manufacturing.
• Familiarity with database management, system validation, and software lifecycle management.
• Basic understanding of data governance principles (controlled vocabularies, data dictionaries, master data ownership).
• Exposure to regulatory inspections and providing LIMS-related documentation.
• Prior experience supporting user training or developing SOPs/guides for LIMS users.

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 primarily performed in a temperature-controlled office environment with standard business equipment. The role involves frequent sitting or standing, computer work, and fine hand manipulation, with occasional lifting or carrying of items up to 25 pounds. A standard Monday–Friday schedule applies, with flexibility for hybrid work, overtime, or limited travel as needed.

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

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.

Position Overview:   

The Laboratory Coordinator, QC Analytical Testing is responsible for day-to-day coordination of laboratory operations to ensure that QC spaces are well-maintained, and compliant with GMP expectations. Key responsibilities include oversight of laboratory cleaning and 5S activities, support for equipment calibration and preventive maintenance (PM), pipette verifications, and sample shipment for external testing. This role will work closely with the Laboratory Manager and QC staff to support smooth laboratory operations and execution of GMP testing. 

Responsibilities: 

• Assist with scheduling for release and stability testing across all client programs for AAV, plasmids, and cell banks  

• Coordinate and/or perform pipette verifications, equipment calibrations, and equipment preventive maintenance with internal teams and external vendors. 

• Maintain logs and records of completed PM and calibration events in compliance with GMP documentation requirements. 

• Coordinate with QC analysts to ship samples for external contract laboratory testing 

• Support implementation and enforcement of 5S and cleanliness standards across all QC lab spaces. 

• Perform routine walkthroughs to support the AOP program, ensuring labs are organized, stocked, and audit ready. 

• Facilitate material ordering to maintain appropriate warehouse stock for lab materials 

• Coordinate general lab cleaning schedules and liaise with facilities or janitorial staff as needed. 

• Partner with QC staff to ensure proper sample receipt, labeling, storage, and documentation of samples and reagents. 

• Support organization of stability and release samples in monitored cold storage units. 

• Coordinate logistics for QC lab training, including scheduling, tracking completions, and maintaining training files. 

• Partner with the Laboratory Manager and other QC leaders to support onboarding of new analysts. 

• Assist with maintaining laboratory notebooks, equipment binders, and tracking logs. 

• Collaborate with Supply Chain, Facilities, and EHS to ensure timely support of laboratory needs. 

• Serve as a liaison for basic lab operations issues and escalate concerns to the Laboratory Manager as appropriate. 

• Qualifications: 

• Bachelor's degree in scientific discipline (Biology, Chemistry, or related field) or equivalent experience. 

• 1–3 years of experience in a GMP laboratory or QC environment preferred. 

• Working knowledge of laboratory equipment, maintenance practices, and GMP documentation. 

• Familiarity with calibration, PM procedures, or pipette verification is a plus. 

• Strong organizational and time management skills with attention to detail. 

• Proficient in Microsoft Office (Excel, Outlook, Word); experience with LIMS, ELN, or QMS systems is a plus. 

• Effective verbal and written communication skills. 

• Ability to work independently and collaboratively in a fast-paced environment. 

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.  

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.