Director, Operations/Site Leader job

Job Description

Job Title: Director, Operations/Site Leader
Requisition ID: 105555BR

When you join us at Thermo Fisher Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Director, Operations/Site Leader will drive a global manufacturing site for GMP production of cell culture products including cell culture media, process liquids and sera for use in biopharmaceutical manufacturing and research. This position will be located in Grand Island, NY and report directly to the Sr. Director Operations within the Cell Culture Business Unit.

Responsibilities include an intense focus on meeting customer needs in a demanding cGMP environment, leading and ensuring all functions at the sites are functioning at peak efficiency with proper internal communication and interfaces, developing the operations and manufacturing teams while ensuring delivery of high quality products which are in compliance with all applicable cGMP manufacturing regulations.
What will you do?

• Develop and establish strong operating mechanisms to ensure business objectives are met
• Establish a collaborative environment across manufacturing sites under his/her control
• Develop and cascade Op s strategies, goals and objectives as well as strong execution mind-set well aligned with the business and global Ops team
• Coordinate the hiring, training, coaching and annual performance reviews of team. Facilitate and mentor the development of team members and front line leaders to be exceptional players.
• Effectively use prioritization mechanisms to utilize resources across teams to complete required workload.
• Lead site leadership across functions to achieve business unit goals.
• Drive compliance to applicable US FDA and EC Quality System Regulations.
• Establish key performance indicators that drive change and visibility to the team and leadership. Track, trend, and monitor routinely with active data analysis to target and drive results.
• Monitor and manage progress on projects, ensuring key requirements and milestones are met.
• Coordinate the development of action plans when corrective steps (CAPA) are required and implement these in a timely manner.
• Manage budgets, schedules and key operating metrics.
• Define and establish clear objectives and expectations, provide direct feedback routinely for performance management.
• Identify projects and recommend appropriate course of action (e.g., discontinuation, outsource, process improvement) to maximize profitability and supply.
• Execute robust Risk Management practices to maintain high probability of project success, ie, satisfaction of scope, schedule and budget.
• Responsible for assessing resource needs across multiple projects and working with appropriate managers to assign resources per established priorities.
• Ensure effective transfers of new products into production that meet all the Quality requirements for the classification.
• Ensure site wide training is effective and that the team operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective

• Minimum of 7 - 10 years of management experience in a complex manufacturing environment.
• Excellent communication and interpersonal skills both written and verbal and the ability to facilitate team interactions.
• Strong leadership ability with the capability to leverage diverse resources, respond quickly, understand the impact of changes and decisions, facilitate agreement, build collaborative relationships and focus on customer needs.
• Ability to work with individuals at all levels and within all functions to motivate strong results.
• Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
• Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
• Experience in leading an organization in a cGMP environment with a focus on Make to Order (MTO)/Custom products is desirable.
• Audit experience within a cGMP environment with successful outcomes is valuable.
• Ability to partner with and influence key stakeholders including Finance, R&D, Product Management and the Commercial team.
• Must be able to independently manage multiple complex projects concurrently while meeting target dates.
• Demonstrated experience as a change agent with ability to influence and communicate at all levels in the organization.

• Larger site leadership
• Experience in leading an organization in a cGMP environment with a focus on Make to Order (MTO)/Custom products is desirable
• Audit experience within a cGMP environment with successful outcomes is valuable,
• Experience working in a matrix organization utilizing influential skills to achieve desired, business-wide outcomes.
• Knowledge of P&L drivers and experience in utilizing them to achieve excellent results

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