Associate Manager, GMP Support (Tubing Assembly)

Forge Biologics•Columbus, OH

7d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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

Benefits

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan
12 weeks of fully paid parental leave
Annual bonus opportunities for all full-time team members.
401(k) with company match
Special employee discounts, including childcare and dependent care savings.
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
A fully stocked kitchen with free snacks and beverages
Ongoing professional development resources, training, and mentorship programs