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Forge Biologics is seeking an Associate Manager for GMP Support - Tubing Assembly to lead technical and operational activities for tubing assembly operations supporting cGMP manufacturing at their state-of-the-art 200,000-square-foot facility in Columbus, Ohio. The company focuses on enabling access to life-changing gene therapies, particularly AAV manufacturing and related biotech innovations.
In this role, you will serve as the subject matter expert for tubing assembly processes, equipment, materials, and components. You will lead and coordinate day-to-day tubing assembly activities to ensure accuracy, efficiency, and compliance with approved procedures, specifications, and manufacturing schedules. Key responsibilities include designing and implementing tubing assemblies that meet process, manufacturing, and GMP requirements; reviewing, writing, and maintaining technical drawings, SOPs, Work Instructions, Master Production Records, and other controlled GMP documentation; and owning quality system activities including deviations, CAPAs, and change controls in partnership with Quality Assurance.
You will troubleshoot assembly, equipment, material, design, and process-related issues; plan and assign daily activities based on manufacturing priorities and production schedules; and provide technical direction, coaching, mentorship, and training to team members. Additional responsibilities include managing tubing assembly materials, components, and inventory; collaborating cross-functionally with GMP Manufacturing, Quality Assurance, Quality Control, Engineering, Facilities, Supply Chain, and Process Development; and identifying and leading opportunities for process, design, and efficiency improvements.
Forge Biologics emphasizes a culture of H.O.P.E.: hardworking, open, purpose-driven, and engaged. The company is committed to professional development through mentorship, hands-on learning, and advancement opportunities.
REQUIREMENTS:
- Bachelor's degree in engineering, life sciences, chemistry, or related field (or equivalent professional experience)
- 5+ years of experience in GMP manufacturing, biotech/pharma operations, or related regulated manufacturing environments
- 2+ years of experience in a leadership, supervisory, or senior technical role with responsibility for directing, mentoring, or guiding team members
- Strong knowledge of cGMP regulations, FDA guidance, and quality system requirements (21 CFR Part 11, Part 820, ICH guidelines)
- Demonstrated expertise in tubing assembly design, manufacturing processes, equipment operation, and troubleshooting
- Proficiency with technical documentation, SOPs, Work Instructions, and controlled document management
- Experience with deviations, CAPAs, change controls, and quality investigations
- Excellent communication, problem-solving, and cross-functional collaboration skills
- Preferred: Experience with MES, ERP/MRP systems, electronic batch records, or document management systems
- Preferred: Experience supporting regulatory inspections, audits, or quality investigations
