Forge Biologics
LIMS System and Data Administrator, Quality Control(Hybrid)
Forge Biologics - Columbus, Ohio, United States, 43224
Work at Forge Biologics
Overview
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Overview
About Forge
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.
About the Role:
The
LIMS System and Data
Administrator role will be the primary business Administrator for the Veeva Laboratory Information Management System (LIMS) within the Quality Control (QC) group. This role is responsible for entering sample and specification requirements into 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. The LIMS System and Data Administrator will also provide user input and prioritization for system enhancements and new module implementations. This role provides an opportunity to play a significant impact in the success of client gene therapy programs.
What You'll Do: Oversee daily operations of the LIMS system for logging batches, entering QC testing results, and issuing electronic COAs and COTs. Maintain data integrity, security, and compliance within the LIMS system, ensuring adherence to GMP and regulatory requirements. Develop user requirements and test scripts for custom scripts, code, or automation tools to support LIMS integration with analytical instruments and other enterprise systems. Optimize workflows within the LIMS to improve data capture, reporting, and traceability by collaborating with IT and Vendor Managed Services. Implement quality control checks within the system to ensure accurate and compliant data entry. Provide business leadership for the implementation of new LIMS modules, system updates, and enhancements to support QC testing needs. Work closely with IT, QA, and QC leadership to configure system settings, user roles, and permissions. Collaborate with laboratory staff to identify system improvements and customize LIMS functionalities. Provide power user support, troubleshooting issues, and resolving system-related queries within QC. Train QC personnel on LIMS functionalities, data entry procedures, and reporting workflows. Develop SOPs, training materials, and documentation for LIMS system use and best practices. 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. Partner with QC, QA, IT, and Manufacturing teams to ensure seamless integration of the LIMS system into broader operations. Work with external vendors and internal stakeholders to support ongoing LIMS improvements and upgrades. Assist in integrating LIMS with ELN (Electronic Lab Notebook), ERP (Enterprise Resource Planning), and CDS (Chromatography Data Systems). What You'll Bring:
BS or MS in Life Sciences, Biotechnology, or a related field is preferred, with degrees in Computer Science or a related field to be considered as well. Experience administering LIMS in a GMP-regulated QC laboratory (biologics, gene therapy, or pharmaceuticals preferred). Experience with Veeva LIMS or other enterprise LIMS platforms (LabWare, LabVantage, STARLIMS, etc.). Understanding of QC analytical methods, sample types, and AAV manufacturing processes, or viral vector manufacturing is highly desirable. Familiarity with database management, system validation, and software lifecycle management. Experience working in compliance with FDA 21 CFR Part 11, GMP, and data integrity regulations. Ability to generate custom reports, dashboards, and queries within LIMS systems. 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). Preferred Skills:
Coding experience (e.g., SQL, Python, JavaScript, or similar languages) to develop custom LIMS configurations and automation. Experience integrating LIMS with analytical instruments, ERP, ELN, or other enterprise systems. Knowledge of data visualization and reporting tools (e.g., Power BI, Tableau). 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.
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.
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.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
H ARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
O PEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
P URPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
E NGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.
We've Got You Covered
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly Un FORGE ttable.
Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
Competitive paid time off plan
Annual bonus for all full-time employees 401(K) company match Competitive paid time off plan Fully-stocked kitchen with free food/drinks 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care Employee Assistance Program Wellness benefits (financial planning services, mental health counseling, employer paid disability) Onsite fitness facility Professional & Personal development resources
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.
About the Role:
The
LIMS System and Data
Administrator role will be the primary business Administrator for the Veeva Laboratory Information Management System (LIMS) within the Quality Control (QC) group. This role is responsible for entering sample and specification requirements into 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. The LIMS System and Data Administrator will also provide user input and prioritization for system enhancements and new module implementations. This role provides an opportunity to play a significant impact in the success of client gene therapy programs.
What You'll Do: Oversee daily operations of the LIMS system for logging batches, entering QC testing results, and issuing electronic COAs and COTs. Maintain data integrity, security, and compliance within the LIMS system, ensuring adherence to GMP and regulatory requirements. Develop user requirements and test scripts for custom scripts, code, or automation tools to support LIMS integration with analytical instruments and other enterprise systems. Optimize workflows within the LIMS to improve data capture, reporting, and traceability by collaborating with IT and Vendor Managed Services. Implement quality control checks within the system to ensure accurate and compliant data entry. Provide business leadership for the implementation of new LIMS modules, system updates, and enhancements to support QC testing needs. Work closely with IT, QA, and QC leadership to configure system settings, user roles, and permissions. Collaborate with laboratory staff to identify system improvements and customize LIMS functionalities. Provide power user support, troubleshooting issues, and resolving system-related queries within QC. Train QC personnel on LIMS functionalities, data entry procedures, and reporting workflows. Develop SOPs, training materials, and documentation for LIMS system use and best practices. 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. Partner with QC, QA, IT, and Manufacturing teams to ensure seamless integration of the LIMS system into broader operations. Work with external vendors and internal stakeholders to support ongoing LIMS improvements and upgrades. Assist in integrating LIMS with ELN (Electronic Lab Notebook), ERP (Enterprise Resource Planning), and CDS (Chromatography Data Systems). What You'll Bring:
BS or MS in Life Sciences, Biotechnology, or a related field is preferred, with degrees in Computer Science or a related field to be considered as well. Experience administering LIMS in a GMP-regulated QC laboratory (biologics, gene therapy, or pharmaceuticals preferred). Experience with Veeva LIMS or other enterprise LIMS platforms (LabWare, LabVantage, STARLIMS, etc.). Understanding of QC analytical methods, sample types, and AAV manufacturing processes, or viral vector manufacturing is highly desirable. Familiarity with database management, system validation, and software lifecycle management. Experience working in compliance with FDA 21 CFR Part 11, GMP, and data integrity regulations. Ability to generate custom reports, dashboards, and queries within LIMS systems. 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). Preferred Skills:
Coding experience (e.g., SQL, Python, JavaScript, or similar languages) to develop custom LIMS configurations and automation. Experience integrating LIMS with analytical instruments, ERP, ELN, or other enterprise systems. Knowledge of data visualization and reporting tools (e.g., Power BI, Tableau). 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.
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.
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.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
H ARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
O PEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
P URPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
E NGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.
We've Got You Covered
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly Un FORGE ttable.
Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
Competitive paid time off plan
Annual bonus for all full-time employees 401(K) company match Competitive paid time off plan Fully-stocked kitchen with free food/drinks 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care Employee Assistance Program Wellness benefits (financial planning services, mental health counseling, employer paid disability) Onsite fitness facility Professional & Personal development resources