About The Role:   

As a Technical Training Manager within the Quality Management Training team, you’ll play a lead role in training and developing associates on GMP-regulated processes that support our AAV Manufacturing operations. Reporting to the Director, GMP Quality Training, you’ll own the delivery of training through hands-on and classroom instruction, actively observe performance, and mentor associates to ensure they are trained, qualified, and confident in their work. You’ll lead qualification and requalification activities, document results in compliance with GDP, and maintain your own process and gowning qualifications to serve as a subject matter expert. While this position is primarily focused on training delivery and mentoring, you’ll also shape the program by identifying training gaps, sharing feedback with supervisors, and recommending improvements to strengthen training methods, content, and overall effectiveness. 

Responsibilities: 

Training Delivery and Qualification: 

• Serve as a subject matter expert and technical lead for GMP Manufacturing operations, owning the delivery of training through classroom instruction, one-on-one coaching, and hands-on, on-the-job practice. 

• Mentor associates throughout their development, actively observe and evaluate performance, and ensure their successful transition to independent work. 

• Coordinate and lead qualification and requalification activities by assessing proficiency, verifying proper execution of GMP-regulated processes, and ensuring all results are accurately documented in compliance with GDP. 

Training Coordination and Compliance: 

• Take ownership of Manufacturing training program compliance by providing clear, actionable feedback to associates and management on training progress, performance observations, and identified gaps. 

• Be accountable for upholding GMP/GDP expectations through accurate qualification documentation and consistent reinforcement of training standards. 

• Be cross-trained in the Training Management System (e.g., Veeva Vault) to provide oversight and ensure accuracy in recordkeeping, compliance tracking, and reporting when required. 

Program Development and Content Management: 

• Take ownership of developing and maintaining training programs that directly support Manufacturing, working in close partnership with Manufacturing leadership and the Training team. 

• Lead the design of area-specific training content, on-the-job training initiatives, and qualification processes to ensure associates are fully prepared for independent work. 

• Own the revisions, updates, and periodic reviews of training materials, ensuring they remain current with SOPs, process changes, and continuous improvement activities. 

Continuous Improvement and Support: 

• Take ownership of continuous improvement within training programs by monitoring effectiveness, proactively communicating findings to leadership, and driving remediation or enhancements where needed. 

• Identify training gaps, recommend improvements, and implement stronger training methods to elevate associate performance and compliance. 

• Maintain gowning and manufacturing process qualifications to serve as a subject matter expert and technical lead during training activities, ensuring associates are consistently prepared for independent work. 

Qualifications: 

• Associate’s degree in Life Sciences, Biotechnology, or a related technical field required; Bachelor’s degree strongly preferred. Equivalent experience may be considered. 

• 3-5 years of experience in GMP-regulated manufacturing (biotech, pharmaceutical, or medical device), with advanced knowledge of AAV bioprocess manufacturing and aseptic techniques/practices. 

• Demonstrated experience leading training activities, mentoring associates, and serving as a recognized Subject Matter Expert within Manufacturing operations. 

• Proven ability to deliver hands-on, on-the-job training and conduct qualification assessments in compliance with GMP/GDP requirements. 

• Advanced communication and facilitation skills, with the ability to simplify complex technical concepts and engage diverse audiences. 

• Experience working cross-functionally with Manufacturing, Quality, Process Development, and Training teams to align training with both business objectives and compliance requirements. 

• Strong organizational and leadership skills, with the ability to manage multiple training priorities and influence program outcomes. 

• Knowledge of adult learning principles and training design methodologies (e.g., ADDIE). 

• Ability to work onsite in Columbus, Ohio 3-4 days/week on average. 

• Ability to work in a cleanroom environment, that requires wearing full Personal Protective Equipment (PPE), including gowns, gloves, masks, and safety glasses. 

Preferred Skills: 

• Demonstrated success in leading training initiatives, mentoring associates, and serving as a recognized SME within GMP-regulated environments. 

• Expertise in AAV bioprocess manufacturing, including cell culture operations, aseptic techniques, and cleanroom behaviors. 

• Proficiency with electronic training systems such as Veeva Vault or similar platforms, with the ability to interpret and leverage training data. 

• Proven ability to identify training gaps, recommend improvements, and implement enhancements that strengthen program effectiveness. 

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 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 Senior Quality Systems Specialist provides quality systems and operational expertise for the Forge GMP facility in Grove City, OH. The Quality Systems Specialist will provide expertise and guidance in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations. The Quality Systems Specialist will also be responsible for monitoring and improving the internal quality systems policies and workflows at Forge.  

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The Sr. Quality Systems Specialist must demonstrate accountability, transparency, and effective communication cross-functionally and within the Quality team. 

What You’ll Do:

• Serve as a quality resource for quality system principles, including documentation control, change control, deviations, CAPAs, and investigations. 

• Proactively identify and implement items to enhance quality through continuous improvement (CAPA). 

• Make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions that have impact on product release. 

• Author or review and approve investigations, CAPAs and change controls to drive for resolution through root cause analysis. 

• Author or review and approve controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, and Forms. 

• Work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust. 

• Support internal and external audits as needed. 

What You’ll Bring:

• Bachelor’s Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)  

• Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation. 

• Thorough knowledge and application of Good Documentation Practices (GDP). 

• Experience in a GxP environment. 

• Must be self-motivated, organized, and proactive. 

• Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements/guidance documents. 

• Ability to maintain a high degree of accuracy and attention to detail. 

• Ability to deliver results in a fast-paced, multi-tasking environment, and prioritize objectives effectively. 

Preferred Skills: 

• Experience with root cause analysis and investigations, including technical writing skills. 

• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur. 

• Knowledge of biopharmaceutical manufacturing process workflows. 

• Experience supporting inspections performed by FDA and foreign Regulatory Authorities. 

• Experience within a pharmaceutical, biotech, or related industry. 

• Sterile injectable pharmaceuticals or biologics experience is preferred.  

• Experience with Veeva Vault QMS. 

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 CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys BMS. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.

Responsibilities:

• Author, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
• Supports computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc), ERP System (NetSuite).
• Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
• Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge’s quality system.
• Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining validated state.

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field (or equivelant experience).
• 2+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
• Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (BMS) like Metasys.
• Strong technical writing skills and ability to execute protocols with minimal supervision.
• Ability to work onsite (in Columbus, Ohio) 3-4 days/week on average.

Preferred Skills:

• Experience with Veeva Vault platform (QMS or QualityDocs) and BMRAM configuration or validation.
• Hands-on validation of laboratory instruments (e.g., HPLC, UV-Vis,)including software like Empower or Chromeleon.
• Familiarity with Metasys BMS or similar environmental monitoring systems in a GxP facility.
• Experience with electronic execution systems such as Veeva Vault Manager or similar.
• Experience supporting regulatory inspections (FDA, EMA) and responding to CSV-related observations.

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 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.

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: 

Forge Biologics is seeking a Manager to join its Technical Sales team in a highly visible, customer-facing role supporting gene therapy programs. This position serves as a technical authority for AAV-based therapeutic development and manufacturing, engaging directly with scientific and executive leadership at client organizations.

The ideal candidate is a PhD-level scientist with deep expertise across AAV therapeutic development, process development, GMP manufacturing, and associated analytics. This role functions as a technical overlay to commercial and delivery teams, leading peer-to-peer scientific discussions that shape client strategy, program design, and successful CMC pathways.

This role is remote-eligible and requires approximately 30% travel to Forge Biologics’ headquarters in Columbus, Ohio, as well as to domestic and international client meetings and industry conferences.

Responsibilities:

Pre-Sales

• Serve as the primary scientific and technical interface between Forge Biologics, prospective clients, and internal commercial and delivery teams.
• Lead technical scoping and program strategy development through proposal and contract execution stages.
• Represent Forge Biologics as a subject matter expert in client engagements, addressing complex technical questions and influencing program direction through credible scientific insight.
• Partner with Sales to develop account growth strategies and support expansion of existing and new client relationships.
• Build and maintain trusted, senior-level relationships with client technical and scientific leadership.
• Develop and deliver high-impact technical proposals, presentations, and sales materials that clearly articulate Forge’s capabilities and competitive differentiation.
• Actively represent Forge Biologics at industry conferences, trade shows, and client meetings as a visible technical leader in the gene therapy space.

Delivery

• Collaborate closely with Client Relations, Project Management, and technical delivery teams to ensure successful execution of contracted programs.
• Provide program insight during routine client delivery calls.
• Support timely evaluation and scoping of Change Order requests.
• Participate in Client Joint Steering Committee meetings, contributing technical insight alongside commercial partners and Forge leadership.

Qualifications:

• Bachelor’s degree in Life Sciences, Biotechnology, or a related field required; advanced degree (Master’s or PhD) highly preferred.
• Significant hands-on experience in the biotechnology or pharmaceutical industry, with a strong preference for experience in MS&T, GMP manufacturing, Process Engineering, Process Development, or related disciplines.
• Deep technical expertise in gene therapy development and manufacturing, with the ability to translate complex scientific concepts for diverse audiences.
• Strong understanding of drug development, regulatory expectations, and market dynamics within the gene therapy field.
• Exceptional relationship-building, influencing, and stakeholder management skills.
• Excellent verbal and written communication, negotiation, and presentation abilities.
• Willingness to travel up to 30%.

Preferred Skills:

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. 

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: 

We are seeking a detail-oriented and highly motivated individual to join our GMP Manufacturing, Upstream team. As a Technician I, GMP Manufacturing - Upstream you will play a critical role in the production and cultivation of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position offers an exciting opportunity to contribute to the development and manufacturing of cutting-edge therapies that have the potential to transform the lives of patients. 

Responsibilities:

• Execute upstream manufacturing operations, including but not limited to cell culture expansion, transfection, and harvest steps, according to Standard Operating Procedures (SOPs) and batch records. 
• Prepare and operate bioreactors, centrifuges, filtration systems, and other equipment required for upstream processing, ensuring they are properly calibrated and maintained. 
• Perform media and buffer preparation, as well as the aseptic transfer of materials, adhering to cGMP guidelines and maintaining a clean and organized work area. 
• Monitor critical process parameters during manufacturing operations and report any deviations or abnormalities to the supervisor in a timely manner. 
• Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis, to ensure optimal culture conditions and product quality. 
• Document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies. 
• Collaborate with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents related to upstream manufacturing processes. 
• Participate in process improvement initiatives and support the implementation of new technologies, equipment, and methods to enhance manufacturing efficiency and productivity. 
• Follow safety procedures and adhere to environmental health and safety guidelines to maintain a safe working environment. 
• Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes. 

Qualifications:

• Associate’s or Bachelor’s degree in a scientific field, or relevant industry certifications; or high school diploma with +2 years of related experience.
• Previous experience working in a regulated manufacturing or laboratory environment.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
• Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Strong problem-solving skills and ability to identify and escalate issues as needed.
• Ability to adapt to changing priorities and work independently as well as part of a team.
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing production schedules.
• Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

Preferred Skills:

• Prior experience working in a cGMP manufacturing environment.
• Upstream bioprocessing or biologics manufacturing experience.
• Familiarity with cell culture techniques, bioreactors, centrifuges, and filtration systems
• Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

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

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:   

We are currently seeking a Lab Materials Manager, Supply Chain to join the Forge Biologics team. The Lab Materials Manager, Supply Chain will directly contribute to the strategic, operational, and supply chain activities required to support our Laboratory programs and vision. The Lab Materials Manager will have oversight of laboratory inventory and will be responsible for coordination of teams in synergy with all internal groups to ensure schedule attainment for our internal and external clients. This role will manage Inventory levels and flow for both internal and external gene therapy programs. The candidate will utilize existing material handling methods as well as being responsible for leading a team responsible for material handling needs for all laboratory teams. The ideal candidate will have experience in modern supply chain methodologies, inventory management systems, be highly organized, have previous management experience, be able to use or willing to learn to operate industrial equipment (For example lift trucks, reach trucks, fork lifts, order pickers, etc), and able to prioritize their schedule to meet the needs of internal and external customers. 

Responsibilities: 

• Develop and implement inventory strategies that align with the Laboratory’s overall goals and objectives.  

• Collaborate with multiple R&D and Lab teams to ensure appropriate levels of inventory to support product development, manufacturing, and distribution requirements. 

• Identify opportunities for Inventory optimization and efficiency improvements within the Laboratory supply chain. Implement best practices and innovative solutions to enhance overall supply chain performance. 

• Robust data analysis of demand and usage to identify optimal stocking levels in the labs, warehouse, and with alignment with financial and business initiatives. 

• Oversee the logistics and distribution processes of moving materials to the labs, including transportation, warehousing, and order fulfillment.  

• Works directly with Laboratory personnel to ensure process communications are occurring in a timely manner and budget and timelines are being adhered to. 

• Work with the processes and systems that support material handling activities including receiving, storing, labeling, controlling, re-stocking laboratory products or materials. 

• Manages the materials space requirement plan and inventory plan in concert with the operational schedules in partnership with the Demand Plan and Planning Team. 

• Use forecasting data to help drive procurement decisions with the Procurement team, ensure adequate inventory levels, and prevent supply shortages. 

• Contributes to the SMOG (Slow Moving/Obsolete Goods) program and coordinates disposition with Forge partners to maximize inventory valuation 

• Lead, mentor, and develop a team of supply chain professionals. Foster a collaborative and results-oriented team culture. 

• Lead a team within the Supply Operations Warehouse team, and act as liaison between management and the team 

• Coordinating with other workers to resolve discrepancies between inventory and ERP transactions. Including mentoring and training new associates how to identify and resolve independently. 

• Performing extensive research on a wide range of inventory-related reports 

• Creating and utilizing advanced inventory reporting to optimize warehouse operations 

• Leading discussions with Supply Chain and other groups to ensure adequate inventory levels are maintained throughout the Research & Development inventory streams 

Qualifications: 

• Bachelor's degree in Supply Chain Management, Operations Management, Business Administration, or a related field. MBA or advanced supply chain certification is a plus. Additional Years of experience may substitute for this requirement. 

• 5+ years’ experience in supply chain or laboratory operations within pharmaceutical, biopharmaceutical manufacturing or other highly regulated environments. 

• In-depth understanding of GMP regulations and quality systems related to pharmaceutical manufacturing.  

• Proven track record of successfully managing complex supply chain operations, including vendor management, demand forecasting, inventory optimization, and logistics.  

• Strong leadership qualities with the ability to inspire and motivate a team. 

• Previous experience in leading teams and cross functional groups 

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

Preferred Skills: 

• Industrial Equipment Certifications 

• Examples include lift trucks, reach trucks, fork lifts, order pickers, etc 

• Previous experience with standard Inventory Management systems (ERP) 

• Strong Leadership skills, and experience in managing teams 

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 warehouse and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The noise level is usually moderate. This role utilizes a computer and other standard warehouse equipment such as powered industrial trucks and hand trucks. In this role, a candidates regularly move freight, stock, or other materials to and from storage or production areas, loading docks, delivery vehicles, etc. Must be able to lift, carry, push, and/or pull objects weighing up to 50 lbs. Standard PPE and safety shoes are required to be worn for this role. They regularly communicate with others in person and electronically. Must have the ability to move around the facility for extended periods of time.  

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 a Technician I, GMP Manufacturing - Downstream you will play a vital role in the production and purification of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position offers an exciting opportunity to contribute to the development and manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

Responsibilities:

• Perform routine downstream manufacturing operations, including but not limited to chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, according to Standard Operating Procedures (SOPs) and batch records.
• Prepare and operate equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring they are properly calibrated and maintained.
• Execute purification processes for AAV-based gene therapy products, adhering to cGMP guidelines and maintaining a clean and organized work area.
• Monitor critical process parameters during manufacturing operations and report any deviations or abnormalities to the supervisor in a timely manner.
• Perform in-process testing and quality control checks, such as pH, conductivity, and pressure measurements, to ensure product quality and compliance with specifications.
• Assist in the execution of process validation and technology transfer activities, collaborating with cross-functional teams to ensure successful execution and timely completion.
• Follow safety procedures and adhere to environmental health and safety guidelines to maintain a safe working environment.
• Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.

Qualifications:

• Associate’s or Bachelor’s degree in a scientific field, or relevant industry certifications; or high school diploma with equivalent professional experience.
• Experience working in a laboratory or regulated manufacturing environment.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
• Strong teamwork and communication skills to collaborate effectively across departments.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Ability to adapt to changing priorities and work independently as well as part of a team.
• Strong problem-solving skills and ability to identify and escalate issues as needed.
• Ability to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.
• Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

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 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. Must be able to lift heavy objects up to 50 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 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.  

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.  

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 Operations Planner is responsible for developing, maintaining, and optimizing integrated production schedules to support gene therapy manufacturing operations. This role ensures alignment across Clinical and Commercial GMP Manufacturing, Supply Chain, Quality, Plasmids, Process Development, Sales, Finance, and Program Management while balancing capacity constraints, material availability, and regulatory requirements in a highly controlled, yet constantly evolving, environment.

Responsibilities:

• Develop and manage master production schedules (MPS) for gene therapy manufacturing and corresponding support activities.
• Translate clinical and commercial demand forecasts into feasible manufacturing plans considering cleanroom capacity, equipment availability, labor, and campaign strategies.
• Coordinate closely with Manufacturing, Quality, Supply Chain, MSAT, and Project Management to ensure schedule adherence and rapid issue resolution.
• Monitor material readiness (critical raw materials, single-use components, vectors, etc) and proactively identify supply risks impacting production timelines.
• Lead short- and long-range capacity planning to support pipeline growth, tech transfers, and scale-up activities in order to advise the Commercial team on available openings for new clients
• Manage and communicate schedule changes driven by deviations, investigations, equipment downtime, resource limitations, or other applicable constraints.
• Analyze planning performance metrics (e.g., schedule adherence, capacity utilization, on-time delivery, days of supply, inventory turns, etc) and drive continuous improvement initiatives.
• Maintain accurate planning data within ERP/MRP systems (Netsuite, SmartSheets, PowerBI and customized excel tools).
• Create process appropriate SOPs and Work Instructions, as it relates to planning accountabilities and update existing documentation, with a Continuous Improvement mindset.
• Participate in S&OP / IBP processes, scenario modeling, and risk mitigation planning.
• Listens attentively to internal departments and team members to relay information, responsibilities, and policies respectfully, effectively, and clearly

Qualifications:

• Bachelor’s degree in Supply Chain, Operations Management, Life Sciences, or related field
• 3+ years of experience in Operations Planning, Production Planning, or Materials Planning within biotech, pharmaceuticals, or GMP manufacturing facility
• Strong understanding of GMP manufacturing environments and regulated production workflows
• Comfortable in a fast paced and ever changing organization, where ambiguity of process exists
• Experience planning complex, multi-step processes with long lead times and constrained capacity
• Proficiency with ERP/MRP systems and advanced Excel or planning tools
• Strong analytical, communication, and cross-functional collaboration skills
• Committed to working in a team environment and supporting business in a respectful manner

Preferred Skills:

• Experience in cell and gene therapy, viral vectors (AAV, lentivirus), or similar manufacturing
• Familiarity with patient-specific or small-batch manufacturing models
• APICS certification (CPIM / CSCP) or similar
• Experience with capacity modeling and scenario planning tools

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  

Role resides in an office setting, with potential to be hybrid, based on mastery of role responsibilities and pertinent business needs.

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.