The GMP Facility Supervisor is responsible for the day-to-day supervision of manufacturing operations personnel and activities within Abzena's current Good Manufacturing Practice (cGMP) production areas, as well as oversight of janitorial and site cleaning services. This role ensures that batch manufacturing, in-process testing support, equipment operation, facility cleanliness, and documentation practices are executed safely, on schedule, and in full compliance with cGMP requirements, approved batch records, SOPs, and applicable regulatory standards. The position serves as a frontline leader responsible for staffing, training, performance management, and shift-level execution of the production schedule.
The GMP Facility Supervisor collaborates closely with Quality Assurance, Quality Control, Validation, Engineering, Facilities, Supply Chain, and Manufacturing Science and Technology to ensure production areas, equipment, and personnel remain compliant, inspection-ready, and capable of consistently supporting GMP manufacturing operations.
Requirements- Supervise day-to-day GMP manufacturing operations to ensure production activities are performed safely, on schedule, and in full compliance with cGMP requirements and regulatory expectations.
- Directly supervise, train, coach, mentor, and develop manufacturing operators and technicians, including scheduling, performance evaluations, hiring recommendations, and disciplinary/termination recommendations as needed.
- Review and approve executed batch production records, logbooks, and associated GMP documentation for accuracy, completeness, and compliance, utilizing SAP, MES, or equivalent systems for batch close-out and reporting, prior to Quality Assurance release.
- Ensure operators are trained and qualified on current SOPs, batch records, and equipment prior to performing GMP manufacturing activities.
- Oversee shift staffing, work assignments, and production scheduling to meet manufacturing targets and client delivery timelines.
- Serve as a key resource for troubleshooting manufacturing deviations, equipment malfunctions, and process issues encountered on the production floor.
- Author, review, and revise SOPs, batch records, and work instructions to reflect current practices and continuous improvement initiatives.
- Initiate, lead, and drive to closure deviation investigations, CAPAs, change controls, and root cause analyses related to manufacturing operations, in partnership with Quality Assurance.
- Enforce safety, gowning, and cGMP behavioral standards within production areas, including cleanroom and controlled environment protocols, and maintain manufacturing areas to site 5S/6S cleanliness and organization standards.
- Oversee janitorial services and site cleaning operations, including scheduling, quality checks, vendor/contractor coordination, and compliance with GMP cleaning and sanitation requirements across classified and non-classified areas.
- Coordinate with Quality Assurance to support batch disposition, in-process quality checks, and real-time release activities.
- Monitor and report key performance indicators such as batch yield, right-first-time, schedule adherence, and equipment downtime.
- Support internal and client audits and regulatory inspections by providing manufacturing documentation, floor walkthroughs, and subject matter expertise.
- Represent Manufacturing Operations in client meetings, project team calls, and technical discussions as the subject matter expert for assigned production processes.
- Ensure proper use, cleaning, and maintenance of manufacturing equipment, including coordination of calibration and preventive maintenance activities with Engineering.
- Manage material and component readiness, including staging, reconciliation, and accountability of GMP materials used in production.
- Participate in technology transfer, process validation, and new product introduction activities as a manufacturing operations representative.
- Identify and lead continuous improvement initiatives to enhance manufacturing efficiency, right-first-time performance, and operator engagement.
- Serve as backup to the Manufacturing Manager/Associate Director as needed, including escalation of critical production and compliance issues to site leadership.
Physical Requirements- Ability to work in office, GMP manufacturing, cleanroom, warehouse, and utility environments.
- Ability to wear required personal protective equipment (PPE) and cleanroom gowning for extended periods.
- Ability to work occasional off-shift hours, weekends, or extended shifts to support production schedules.
- Ability to sit, stand, walk, and utilize computer systems for extended periods.
- Ability to lift up to 25 pounds occasionally.
Qualifications- Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or related discipline required; equivalent education/experience combinations considered in lieu of degree (e.g., Associate's degree with 7+ years, or High School diploma/GED with 9+ years, of relevant GMP manufacturing experience), consistent with 21 CFR 211.25(b) supervisor qualification requirements.
- Minimum 5 years of experience in GMP manufacturing operations (8+ years if without a qualifying degree), including at least 2 years in a formal or informal supervisory, lead, or shift-lead capacity, within a pharmaceutical, biotechnology, or related regulated manufacturing environment.
- Strong working knowledge of cGMP regulations, FDA requirements, EU Annex 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 or client inspections.
- Strong leadership, coaching, and performance management skills with the ability to motivate and develop production teams.
- Strong analytical, organizational, and problem-solving skills, with the ability to make sound decisions under time pressure.
- Proficiency in Microsoft Office (Excel, Word, Outlook) and manufacturing execution systems (MES), CMMS, or ERP platforms.
- Ability to communicate effectively across all levels of the organization, including cross-functional teams and site leadership.
- Experience overseeing janitorial, custodial, or facility cleaning services, including vendor management, in a regulated or GMP environment preferred.
- Experience with aseptic processing, biologics, or drug substance/drug product manufacturing preferred.
FLSA: Exempt
