Associate Manager, GMP Manufacturing Support

The role

This role provides technical and operational leadership for tubing assembly activities supporting GMP manufacturing operations. The person will lead assembly designs, maintain technical documentation, and ensure compliance with cGMP requirements.

What you will do

• Lead and coordinate day-to-day tubing assembly activities
• Serve as the subject matter expert for tubing assembly processes, equipment, materials, and components
• Lead the design, development, and implementation of tubing assemblies
• Review, write, revise, and maintain technical drawings, SOPs, Work Instructions, and Master Production Records
• Own and lead deviations, CAPAs, change controls, and other quality system activities
• Troubleshoot tubing assembly, equipment, material, design, and process-related issues
• Plan and assign daily tubing assembly activities based on manufacturing priorities and staffing
• Provide technical direction, coaching, mentorship, and training to team members
• Manage tubing assembly materials, components, consumables, and inventory
• Collaborate cross-functionally with GMP Manufacturing, Quality, Engineering, and other departments

Required 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

Nice to have

• 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

Benefits

• Health, dental and vision insurance start your first day with 90% of premiums covered for you and your family
• Competitive paid time off plan
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 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 Employee Assistance Program
• Employer-paid short and long-term disability coverage
• Fully stocked kitchen with free snacks and beverages
• Ongoing professional development resources, training, and mentorship programs

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.