GMP Manufacturing Supervisor – Biologics & Cleanroom

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 110,000 - 160,000; Full time

Job summary

Abzena Inc. is seeking a GMP Facility Supervisor to lead day-to-day manufacturing operations in a cGMP environment. You will supervise operators, ensure batch records and SOPs are correctly followed, and drive continuous improvement initiatives on the production floor.

You will collaborate with QA, Validation, Engineering, Facilities, and Supply Chain to maintain inspections readiness and compliant operations. Strong leadership and 5+ years in GMP are required.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or related discipline or equivalent education/experience
• Minimum 5 years of experience in GMP manufacturing operations (8+ years if without a qualifying degree)
• Strong knowledge of cGMP regulations, FDA requirements, EU guidelines, and data integrity principles
• Experience executing, reviewing, and approving batch production records, SOPs, and controlled GMP documentation
• Experience supporting deviations, CAPAs, change controls, audits, and regulatory/client inspections
• Strong leadership, coaching, and performance management skills with the ability to motivate and develop production teams

Responsibilities

• Supervise day-to-day GMP manufacturing operations to ensure production activities are performed safely, on schedule, and in full compliance with cGMP requirements
• Directly supervise, train, coach, mentor, and develop manufacturing operators and technicians, including scheduling and evaluations
• Review and approve batch production records, logbooks, and GMP documentation prior to QA release
• Ensure operators are trained and qualified on SOPs and equipment
• Oversee shift staffing and production scheduling to meet targets and client delivery timelines
• Coordinate with QA to support batch disposition and in-process quality checks
• Lead deviation investigations, CAPAs, change controls, and root-cause analyses with QA
• Maintain 5S/6S cleanliness and enforce GMP safety and gowning standards
• Manage vendor coordination for janitorial services and site cleaning in GMP environments
• Participate in technology transfer, process validation, and new product introduction as a manufacturing operations representative
• Support internal and client audits and regulatory inspections with documentation and floor walkthroughs
• Represent Manufacturing Operations in client meetings and technical discussions

Skills

Leadership

Coaching

Performance management

Data integrity

Education

Bachelor's degree in Life Sciences or related field

Tools

SAP

MES

CMMS

ERP systems

Job description

Abzena Inc. is seeking a GMP Facility Supervisor to lead day-to-day manufacturing operations in a cGMP environment. You will supervise operators, ensure batch records and SOPs are correctly followed, and drive continuous improvement initiatives on the production floor.

You will collaborate with QA, Validation, Engineering, Facilities, and Supply Chain to maintain inspections readiness and compliant operations. Strong leadership and 5+ years in GMP are required.