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 functions)
- Strong understanding of cGMP requirements, manufacturing documentation, and quality systems
- Experience 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 
