Manufacturing Operations Manager – 503B Outsourcing Facility

The Manufacturing Manager reports directly to the General Manager and is responsible for leading daily manufacturing operations within an FDA-regulated 503B outsourcing facility. This role oversees multiple production functions including material handling and warehousing, formulation, aseptic filling, visual inspection, labeling, and facility sanitization.

The Manufacturing Manager is responsible for driving operational excellence, ensuring compliance with cGMP requirements, meeting production schedules, developing high-performing teams, and supporting continuous improvement initiatives across the manufacturing organization. This position requires a strong leader who can balance quality, compliance, employee development, and operational efficiency in a fast-paced sterile manufacturing environment.

The Basics:

Location: Albany, Ohio
Job Type: Regular Full-Time
Schedule: Monday–Friday, 6 AM–2:30 PM
Compensation: $100,000 - $125,000

How You'll Make an Impact:

• Provide leadership, direction, and development for manufacturing teams supporting warehousing, formulation, aseptic processing, inspection, labeling, and facility sanitization. Additional operational oversight may be assigned based on business needs.
• Build and sustain a high-performance culture through effective coaching, employee development, performance management, accountability, recognition, and clear communication.
• Manage department staffing, scheduling, labor utilization, attendance, and workforce planning to ensure production demands are met safely and efficiently.
• Ensure all manufacturing activities are executed in compliance with current U.S. Food and Drug Administration (FDA) cGMP requirements, internal procedures, batch records, and site quality standards.
• Ensure Standard Operating Procedures (SOPs), batch documentation, training records, and manufacturing documentation remain current, accurate, and audit-ready.
• Monitor and analyze key operational metrics including production output, labor efficiency, downtime, deviations, rejects, scrap, and yield performance. Develop and implement corrective actions to improve performance.
• Lead investigations related to deviations, non-conformances, documentation errors, and process failures. Partner with Quality to complete root cause analysis, implement CAPAs, and ensure timely product disposition.
• Drive continuous improvement initiatives focused on safety, quality, compliance, throughput, cost reduction, and process reliability.
• Support production planning and cross-functional coordination with Quality, Supply Chain, Engineering, Validation, and Facilities to ensure uninterrupted operations.
• Manage departmental budgets, resource allocation, and spending to meet operational and financial objectives.
• Lead problem-solving activities and escalate critical operational risks as needed.
• Support regulatory inspections, internal audits, client audits, and remediation activities as required.
• Ability to travel between 10-15%, if applicable

What We're Looking For:

• Strong working knowledge of U.S. Food and Drug Administration cGMP, aseptic processing principles, and pharmaceutical manufacturing requirements.
• Demonstrated leadership skills with the ability to motivate teams, drive accountability, and develop talent.
• Strong analytical and problem-solving skills with experience using data to drive operational decisions.
• Excellent written, verbal, and presentation communication skills.
• Ability to manage multiple priorities and adapt quickly in a fast-paced manufacturing environment.
• Proficiency in Microsoft Office applications, including Excel, Word, and performance reporting tools.
• Strong results orientation with a focus on safety, quality, compliance, and operational execution.

Required Credentials:

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Operations, or a related technical discipline; equivalent experience may be considered in lieu of degree.
• Minimum of 2 years of experience in sterile manufacturing, aseptic processing, or pharmaceutical production environments.
• Minimum of 2 years of leadership or supervisory experience in an FDA-regulated cGMP manufacturing environment.
• Experience in sterile compounding, injectables, or aseptic fill-finish operations strongly preferred.
• Experience with investigations, CAPA management, deviation management, and continuous improvement methodologies preferred.

Physical Requirements:

• Ability to stand, walk, and move throughout manufacturing, warehouse, and office areas for extended periods of time.
• Ability to wear required personal protective equipment (PPE), including gowning for cleanroom and controlled environment areas, for extended periods.
• Ability to perform repetitive motions such as bending, reaching, crouching, and climbing stairs or ladders as needed to support operations.
• Ability to occasionally lift, push, pull, or move materials and equipment up to 25 pounds; heavier items with assistance or appropriate equipment.
• Ability to work in controlled manufacturing environments, including cleanrooms with varying temperatures, humidity levels, and noise conditions.
• Ability to use computer equipment and standard office tools for extended periods while reviewing documentation, analyzing data, and supporting operational activities.

What You'll Love About Wedgewood:

• Competitive compensation and benefits
• Opportunities for growth and career development
• A supportive, team-first culture when your work matters
• The ability to make a real impact on animal health every day