Manufacturing Operations Manager – 503B Outsourcing Facility

The Basics

Location:

Albany, Ohio

Job Type: Regular Full-Time

Schedule:

Monday–Friday, 6 AM–2:30 PM

Compensation: $100,000 - $125,000

• 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 elevate 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.

• 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.

• 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.

• 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 clean rooms 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.

• 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

Wedgewood Pharmacy is an equal opportunity employer. We are committed to building a diverse and inclusive workplace where everyone can thrive.