Job Title: Operations Manager

Work Location: Monroe County, New York

Summary:

The Operations Manager is responsible for overseeing daily manufacturing operations, ensuring safety, compliance, and efficiency in a GMP-regulated environment. This role provides leadership to production teams, drives continuous improvement, and ensures audit readiness through documentation and procedural excellence.

Responsibilities:

• Direct daily manufacturing activities, ensuring all operations are performed safely and in compliance with batch records, SOPs, and data integrity standards.
• Lead and mentor production staff, ensuring consistent execution of unit operations, including CIP and waste-water treatment systems, and maintaining readiness for inspections.
• Utilize performance management tools and shop floor audits to identify and resolve operational gaps, driving rapid issue closure and continuous improvement.
• Coordinate with cross-functional teams to support deviation investigations, change controls, and process optimization, including system set-up and certification activities.
• Oversee real-time, accurate documentation of operations using electronic batch records, ensuring adherence to ALCOA+ principles and audit readiness.
• Challenge and improve existing processes, SOPs, and documentation, while maintaining high standards for housekeeping and compliance through regular audits.
• Track, report, and improve key performance indicators such as OEE, yield, waste, and customer service metrics, utilizing D365 systems for plant optimization.
• Participate in internal audits and regulatory inspections, representing manufacturing and ensuring proactive compliance with all procedural requirements.

Qualifications:

• Bachelor’s degree in Biotechnology, Chemical Engineering, Life Sciences, or related field preferred; equivalent bioprocessing experience may be considered.
• 5–7 years of experience in GMP-regulated manufacturing, with at least 2 years in a supervisory or leadership capacity.
• Proven experience with bioprocess operations, equipment troubleshooting, and process optimization in a regulated environment.
• Familiarity with deviation management, change control, and root cause analysis processes.
• Strong leadership, organizational, and communication skills, with the ability to manage shift operations and collaborate across departments.
• Deep understanding of GMP workflows, batch record execution, and documentation best practices.
• Skilled in coaching and mentoring staff on compliance, aseptic operations, and data integrity.
• Proficient in interpreting process data, identifying trends, and resolving operational challenges.
• Ability to work in a GMP-controlled environment, adhere to gowning/PPE requirements, and maintain a strong presence on the production floor.
• Physical ability to stand, walk, and occasionally lift up to 50 lbs; willingness to work variable shifts, including evenings or weekends as needed.
• Experience maintaining audit readiness through documentation oversight, procedural compliance, and team leadership.

Published Category: Manufacturing & Technical Operations