Production Manager, Sterile Injectables

The Production Manager leads the Production department and is responsible for the safe, compliant, and efficient manufacture of sterile injectable products. This role oversees production execution, staffing, scheduling, employee performance, and manufacturing results while ensuring adherence to approved procedures, quality standards, and cGMP requirements.This hands-on leadership position requires a strong presence on the manufacturing floor, practical expertise in aseptic operations, and the ability to develop teams, resolve operational problems, and improve production performance.Key ResponsibilitiesLead daily sterile injectable production operations, including staffing, production readiness, schedule execution, and coordination of manufacturing activities across applicable shifts.Direct and develop production supervisors, leads, and operators through clear expectations, coaching, training, and performance management.Ensure manufacturing activities comply with approved batch records, SOPs, cGMP requirements, aseptic practices, gowning procedures, and contamination control measures.Oversee applicable manufacturing activities, including compounding, component preparation, sterilization, and aseptic filling, ensuring personnel are appropriately trained and qualified.Partner with Supply Chain, Quality, and other support functions to establish achievable production schedules and ensure the availability of materials, equipment, personnel, and approved documentation.Maintain a strong manufacturing-floor presence to address operational issues, reinforce procedural compliance, and promptly escalate equipment failures, process abnormalities, or quality concerns.Ensure accurate, timely completion and production review of batch records, equipment logs, and other manufacturing documentation.Lead production’s contributions to deviations, investigations, root-cause analysis, CAPAs, and change controls, and support regulatory inspections and audits.Monitor production performance and implement improvements that increase yield, throughput, and schedule attainment while reducing downtime, waste, and recurring errors.Coordinate with Engineering, Maintenance, and Validation on equipment readiness, troubleshooting, maintenance, qualification activities, and manufacturing improvements.What We’re Looking ForExperience7+ years of pharmaceutical manufacturing experience, including at least 5+ years in sterile injectable or aseptic manufacturing.3+ years of formal production leadership experience, including responsibility for staffing, employee performance, training, and production execution.Demonstrated experience managing a production department, multiple manufacturing teams, or a substantial sterile manufacturing operation.Experience supporting investigations, deviations, CAPAs, change controls, and inspection readiness in a cGMP environment.Experience leading supervisors or team leads and coordinating production across multiple shifts preferred.EducationBachelor’s degree in Engineering, Pharmaceutical Sciences, Biology, Chemistry, or a closely related technical or scientific discipline preferred.An equivalent combination of education and substantial, directly relevant sterile manufacturing and production leadership experience will be considered.Skills & KnowledgeStrong practical knowledge of sterile injectable manufacturing, aseptic processing, cleanroom operations, and contamination control.Strong people-management skills, including coaching, performance management, workforce planning, and team development.Ability to manage production schedules, allocate resources, and resolve operational problems while maintaining quality and safety standards.Ability to analyze production performance and implement sustainable improvements in yield, efficiency, downtime, and throughput.Strong working knowledge of cGMP documentation, data integrity, batch record execution, and quality systems.Effective communication and collaboration with manufacturing personnel, technical teams, Quality, and site leadership.What We OfferCompetitive compensation with annual performance bonus eligibilityAnnual merit-based pay increasesAutomatic enrollment in a 401(k) at 3% pre-tax with a 50% company match on the first 6% contributedPaid Time Off10 paid company holidaysComprehensive medical, dental, vision, and life insurance coverageProfessional development reimbursementCareer growth opportunitiesTuition reimbursement for children and childcare expense reimbursementScheduleFull-time, on-site position (day shift) with flexibility to support production across applicable shifts and occasional off-hours or weekend needs.