Manager Operations

Position Summary

The Operations Manager leads administratively and technically the compounding/dispensing/filling operations of the Sterile Production Operations. Ensure established GMPs and all other requirements of Thermo Fisher Scientific and Quality systems are met. Coordinates and schedules filling activities and budgeted production volumes and goals are met. Ensures appropriate training standards for the operations are established and personnel is trained appropriately. Ensures the lowest possible cost of goods in compliance with existing rules and regulatory requirements.

Key Responsibilities

• Responsible for the day to day operation of one Sterile manufacturing and filling lines including three Freeze Dryers; maintain compliance status of area, assure schedules are established/maintained, and perform oversight to ongoing operations and troubleshooting.
• Lead filling operations by directing the production activities daily and ensuring scheduled activities are performed as planned.
• Ensure GMP compliance and meet requirements of Thermo Fisher quality systems.
• Ensure production efficiencies are monitored and action taken to lower variable standard costs.
• Manage administrative aspects of the group including performance plans, job descriptions, employee performance reviews, hiring, rewarding, disciplining, professional development, teamwork, and assigning responsibility and accountability.
• Prepare expense and headcount budgets and ensure budget targets are met while providing adequate resources to meet customer demands.
• Support the company's safety program to improve safety awareness and provide a safe work environment.
• Comply with all job-related safety and other training requirements.
• Apply technical and operational knowledge of Aseptic processing operations, balancing multiple ongoing activities and prioritizing tasks; serve as key interaction with customers in commercial operation and handle customer and regulatory interactions.

Qualifications

• Bachelor's degree in Science in Engineering, Operations Management or related field is required; equivalent combinations of education, training, and relevant work experience may be considered.
• 6+ years of pharmaceutical operations or quality experience and at least 2+ years in a significant management role is required.
• Experience in a large Pharma company in product development would be preferred.
• Technical and operational knowledge in pharmaceutical or medical devices environment preferable.
• Attention to detail and organizational skills; self-starter, mature, independent and dependable.
• Ability to work in a fast-paced environment under pressure.
• Able to identify and implement process improvement initiatives to reduce cost and increase efficiencies in the operations.
• Effective time management and prioritization skills.
• Effective and strategical verbal/written communication skills at all levels.
• High level of social skills to establish and maintain effective working relationships with employees and customers, including tact to handle critical matters.
• Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.
• Ability to handle and lead professional staff to achieve goals, evaluate and resolve complex technical problems.
• Ability to delegate tasks to a group of people.