Forge Biologics
Associate Manager, GMP Manufacturing Support
Columbus, Ohio · Senior
Sponsorship not specifiedDetected 1 day ago
Supply ChainPerformance ManagementGMPMedical DevicesLeadershipMentoring
Stay score
odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- The Associate Manager, GMP Support, provides technical and operational leadership for tubing assembly activities supporting GMP manufacturing operations at Forge Biologics.
- 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.
- 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.
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
- Manage tubing assembly materials, components, consumables, and inventory
Requirements
- Associate's or Bachelor's degree in a relevant scientific, technical, engineering, or manufacturing field, or equivalent experience
- Strong understanding of cGMP requirements, manufacturing documentation, and quality systems
- 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)
- E xperience writing, reviewing, or revising SOPs, Work Instructions, MPRs, or other controlled documents <span d
Skills
- Your Future with Us:
- to enable access to life-changing gene therapies and help bring them from ideas into reality.
- At Forge, your growth matters.
Company info
- 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.
- Here, you won't just watch innovation happen - you'll be part of it.
Apply directly at Forge Biologics →Create a free account for alerts like thisView Forge Biologics immigration profile
This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.