GMP Manufacturing Lead for Biologics

Abzena Ltd; Bristol Township (Bucks County); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Abzena is seeking a GMP Facility Supervisor to lead day-to-day GMP manufacturing operations, ensuring safety, quality, and compliance in a cGMP environment. You will supervise operators, review batch records, and coordinate with QA, QA, and Engineering to maintain production schedules and continuous improvement.

The role requires strong leadership, regulatory knowledge, and experience with SAP/MES, with a focus on training, performance management, and timely issue resolution to meet client

Qualifications

• Bachelor's degree required; 5+ years GMP manufacturing experience; 2+ years supervisory/lead role in pharma/biotech.
• Strong knowledge of cGMP, FDA requirements, EU guidelines, and data integrity principles.
• Experience reviewing/approving batch records, SOPs, and GMP documentation.
• Experience supporting deviations, CAPAs, change controls, audits, and inspections.
• Ability to lead, coach, and develop manufacturing teams and manage performance.

Responsibilities

• Supervise day-to-day GMP manufacturing operations, ensuring safety, on-schedule production, and compliance.
• Directly supervise, train, coach, and develop operators and technicians; handle staffing and scheduling.
• Review and approve batch production records, logbooks, and GMP docs using SAP or MES for close-out.
• Ensure operators are trained on SOPs and equipment prior to GMP activities.
• Oversee shift staffing and production scheduling to meet targets and client timelines.
• Lead investigations into deviations and drive CAPAs and change controls to closure.
• Maintain 5S/6S cleanliness and enforce GMP safety and gowning standards.
• Coordinate with QA for batch disposition, in-process checks, and real-time release activities.
• Support audits/inspections with documentation, floor walkthroughs, and SME input.

Skills

Leadership

Regulatory knowledge

Data integrity

Cross-functional communication

MS Office / MES experience

MES/ERP experience

Education

Bachelor's degree in Life Sciences / related

Associate's degree with 7+ years GMP experience

High School diploma / GED with 9+ years GMP experience

Tools

SAP

MES

CMMS

ERP systems

Job description

Abzena is seeking a GMP Facility Supervisor to lead day-to-day GMP manufacturing operations, ensuring safety, quality, and compliance in a cGMP environment. You will supervise operators, review batch records, and coordinate with QA, QA, and Engineering to maintain production schedules and continuous improvement.

The role requires strong leadership, regulatory knowledge, and experience with SAP/MES, with a focus on training, performance management, and timely issue resolution to meet client