Sterile Operations Director

Xellia Pharmaceuticals - Bedford, OH3.7


Directs and coordinates the daily activities of the Sterile Operations and RTU Departments to ensure both areas are in full compliance with the applicable regulatory agencies while consistently meeting the volume and objectives of the department.


Adheres to the manufacturing plan for the plant site which includes responsibility for the site operating budget, cost of goods, and capital.

Collaborates with all site departments to reach plant goals.
Ensures compliance with company standards for cost control, waste reduction, quality, safety and complete on-time delivery.
Develops long-range strategic plan to help reduce costs and add to the company’s bottom line.
Plans, organizes, integrates and reviews staff resources with the production organization, to successfully meet current production demands and directs a continuous planning strategy to maximize the facility’s capability to meet future commitments.
Ensures compliance with company needs for capital investments and improvement projects.
Formulates and recommends manufacturing improvements to improve profitability.
Supports all corporate direct projects from the plant level.
Ensures continued development of staff to promote and maintain high manufacturing standards.
Works closely with the Quality department to ensure that trends are leading in the right direction, to help support producing a quality product within acceptable time and expense.
Provides leadership for problem resolution to facilitate faster improvements.
Carries out supervisory responsibilities in accordance with the organizations policies.
Follows plant metrics to ensure compliance with company goals.

B.S. degree in Engineering, Pharmacy or related field. Master’s degree preferred.
Minimum of 7 years of experience in pharmaceutical manufacturing in a cGMP environment required. Ten (10) years’ experience preferred.
Minimum of 5 years’ experience in aseptic operations. Ten (10) years’ experience preferred.
Minimum of 2 years’ experience in Intravenous (IV) bags filling.
Must demonstrate progressive levels of managerial experience and a broad span of organizational control.
Lyophilization experience desirable.
Excellent analytical and technical skills.
Excellent written and verbal communication skills. Must be able to communicate and interact with all levels of the organization and manage in a dynamic environment to meet plant and company objectives.
Ability to interpret financial information.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.