Associate Manager, GMP Support (Tubing Assembly)

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 Associate Manager, GMP Support - Tubing Assembly , provides technical and operational leadership for tubing assembly activities supporting GMP manufacturing operations at Forge Biologics. This role serves as the subject matter expert for tubing assembly processes, documentation, and manufacturing readiness, and is responsible for coordinating day-to-day operations, leading assembly designs, maintaining technical documentation, and ensuring compliance with cGMP requirements. The Lead also owns quality system activities, provides direction and mentorship to team members, and partners cross-functionally to resolve issues and drive continuous improvement.

Responsibilities:

Lead and coordinate day-to-day tubing assembly activities to ensure assemblies are prepared accurately, efficiently, and in accordance with approved procedures, specifications, and manufacturing schedules

Serve as the subject matter expert for tubing assembly processes, equipment, materials, components, and associated manufacturing support activities

Lead the design, development, and implementation of tubing assemblies used to support GMP manufacturing operations, ensuring designs meet process, manufacturing, and GMP requirements

Review, interpret, write, revise, and maintain technical drawings, SOPs, Work Instructions, Master Production Records (MPRs), forms, specifications, and other controlled GMP documentation; ensure all documentation accurately reflects current processes and is maintained in accordance with document control requirements

Own and lead deviations, CAPAs, change controls, and other quality system activities; partner with Quality Assurance to investigate issues, identify root causes, and implement sustainable corrective and preventive actions

Troubleshoot tubing assembly, equipment, material, design, and process-related issues and determine appropriate corrective actions or escalation paths

Plan and assign daily tubing assembly activities based on manufacturing priorities, staffing, material availability, and production schedules; review completed manufacturing documentation and records for accuracy, completeness, and GMP compliance

Provide technical direction, coaching, mentorship, and training to team members on tubing assembly procedures, documentation requirements, and GMP expectations; conduct regular one-on-ones and contribute to performance reviews, goal setting, and development plans

Foster a culture of accountability, teamwork, quality, safety, and continuous improvement within the tubing assembly team

Manage tubing assembly materials, components, consumables, and inventory; monitor availability, expiration dates, storage conditions, and inventory levels to proactively identify and address risks to manufacturing readiness

Collaborate cross-functionally with GMP Manufacturing, Quality Assurance, Quality Control, Engineering, Facilities, Supply Chain, Process Development, and other departments to support tubing assembly designs and resolve technical or operational issues

Identify and lead opportunities for process, design, documentation, and efficiency improvements; participate in continuous improvement initiatives and technical projects supporting safety, compliance, and manufacturing performance

Support regulatory inspections, internal audits, and qualification activities by providing technical knowledge and documentation related to tubing assembly processes

Adhere to cGMP requirements, cleanroom gowning practices, and all applicable safety requirements while working in classified manufacturing environments

Qualifications:

Associate's or Bachelor's degree in a relevant scientific, technical, engineering, or manufacturing field, or equivalent experience

5 + years of experience in a GMP manufacturing, biotechnology, pharmaceutical, medical device, or other regulated manufacturing environment

Direct experience in manufacturing support functions (e.g., cleaning/sanitization, tubing assembly, single-use assemblies, equipment setup , or other related technical manufacturing function s)

Strong understanding of cGMP requirements, manufacturing documentation, and quality systems

E xperience writing, reviewing, or revising SOPs, Work Instructions, MPRs, or other controlled documents

Ability to work independently while providing effective leadership and direction to team members

Experience with deviations, CAPAs, change controls, or other quality system processes

Experience interpreting technical drawings, specifications, or engineering documentation

Ability to work in classified cleanroom environments for extended periods while fully gowned in required PPE

Flexibility to work shifts, including weekends and holidays, as required by manufacturing schedules

Preferred Skills:

Experience in a biologics, gene therapy, viral vector, or sterile manufacturing environment

Experience designing, building, or implementing single-use tubing assemblies and/or creating or reviewing technical/assembly drawings or engineering specifications

Experience leading technical projects or process improvement initiatives

Experience with MES, ERP/MRP systems, electronic batch records, or document management systems

Experience supporting regulatory inspections, audits, or quality investigations

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