Operations Manager (3rd Shift)

Essential Functions

• Manage and oversee manufacturing operations to ensure safe, compliant, and efficient execution of production activities in accordance with SOPs, cGMP requirements, and company standards.
• Ensure manufacturing documentation, batch records, logs, and procedures are maintained accurately, completely, and in an audit-ready state.
• Drive operational excellence by proactively identifying, troubleshooting, and resolving production issues while ensuring the availability of required equipment, materials, and resources.
• Lead deviation investigations, root cause analyses, and the implementation of effective corrective and preventive actions (CAPAs) to minimize recurrence and maintain product quality.
• Partner cross-functionally to support manufacturing objectives and resolve operational challenges.
• Oversee production planning and scheduling activities, including coordination of process validations, equipment qualifications, maintenance activities, and manufacturing priorities.
• Monitor and analyze key performance indicators, production metrics, and operational reports to drive informed decision-making and continuous improvement.
• Identify, recommend, and implement process, equipment, and workflow improvements that enhance safety, quality, compliance, productivity, and cost efficiency.
• Evaluate and recommend strategic investments to improve manufacturing capabilities, capacity, reliability, and long-term business performance.
• Other duties as assigned.

Supervisory Responsibilities

• Directly hire and lead a team of supervisors, leads and technicians.
• Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
• Conduct regular 1:1’s to address performance, feedback and relationship building.
• Identify training and development needs within the team and facilitate as able.

Experience and Necessary Competencies

• Bachelor’s degree in Life Sciences, Pharmacy or Engineering or equivalent experience.
• 5+ years of leadership experience in a cGMP pharmaceutical manufacturing environment.
• Advanced problem solving such as Six Sigma and Lean training, Black belt of Green belt preferred.
• Excellent at bringing others together and reconciling differences effectively.
• Able to work in a fast-paced environment and adaptable to change.
• Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is required
• Proficient written, verbal and oral English communication skills are required.
• Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.

Competencies

• Drive for Results - Consistently achieves goals and delivers high-quality results through accountability, urgency, and execution.
• Process Management - Effectively manages and improves processes to ensure safe, compliant, and efficient operations.
• Problem Solving - Identifies root causes, analyzes issues, and implements effective solutions to operational challenges.
• Managing and Measuring Work - Establishes clear expectations, monitors performance, and holds teams accountable for achieving objectives.
• Building Effective Teams - Develops a collaborative, high-performing team culture that promotes engagement, accountability, and continuous improvement.

Physical Requirements

• Ability to stand or sit for extended periods of time.
• Ability to stoop, crawl, bend, walk for extended periods of time, if applicable.
• Ability to lift, push and pull up to 25 pounds periodically.
• Ability to maintain a gowning qualification.

Schedule

Monday - Friday 11:30pm - 8am