GMP Manufacturing Supervisor - Biologics Ops & Compliance

Abzena Inc.; Bristol (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Abzena Inc. is seeking a GMP Facility Supervisor to lead day-to-day manufacturing operations in our cGMP production areas. You will supervise operators, ensure batch records and SOPs are accurate, and drive continuous improvement in quality and efficiency.

Work closely with QA, QC, Validation, and Engineering to maintain inspection readiness and schedule adherence. A strong background in GMP, FDA/EU guidelines, and data integrity is essential.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or related field; equivalent combinations considered.
• Minimum 5 years of GMP manufacturing operations experience; 2+ years in supervision or lead roles.
• Strong knowledge of cGMP, FDA requirements, EU guidelines, and data integrity.
• Experience reviewing/approving batch records, SOPs, and GMP documentation.
• Experience supporting deviations, CAPAs, change controls, audits, and inspections.

Responsibilities

• Supervise day-to-day GMP manufacturing operations to ensure safety, schedule adherence, and regulatory compliance.
• Directly supervise, train, coach, and develop manufacturing operators and technicians.
• Review/approve batch production records, logbooks, and GMP documentation.
• Ensure operators are trained and qualified on SOPs, batch records, and equipment.
• Oversee shift staffing, production scheduling, and target achievement.
• Lead investigations for deviations and drive CAPAs and root cause analyses with QA.
• Author/ revise SOPs and batch records to reflect current practices and improvements.
• Coordinate calibration, preventive maintenance, and equipment upkeep with Engineering.

Skills

Leadership

Training & coaching

Regulatory compliance

Quality mindset

Problem solving

Communication

Safety

Education

Bachelor’s degree or higher

Tools

SAP

MES

CMMS

ERP systems

Job description

Abzena Inc. is seeking a GMP Facility Supervisor to lead day-to-day manufacturing operations in our cGMP production areas. You will supervise operators, ensure batch records and SOPs are accurate, and drive continuous improvement in quality and efficiency.

Work closely with QA, QC, Validation, and Engineering to maintain inspection readiness and schedule adherence. A strong background in GMP, FDA/EU guidelines, and data integrity is essential.