Manager, Chemistry

Fresenius Kabi USA • Wilson, NC

10d • $90,816 - $126,991 • Onsite

About The Position

The Manager, Chemistry will be responsible for the management of all activities associated with testing of raw material and finished goods to meet established and expected quality, regulatory and customer requirements. Interact with Manufacturing and Quality Assurance on a routine basis.

Requirements

• Management of all activities associated with testing of raw material and finished goods to meet established and expected quality, regulatory and customer requirements.
• Interact with Manufacturing and Quality Assurance on a routine basis.
• Adequately trained, developed and motivated staff.
• Adherence to quality performance standards.
• Development of cross-trained, self-directed work teams.
• Staying current with new and changing analytical chemistry requirements, methods, and pharmaceutical changes.
• Evaluation and decision on corrective actions for OOS or OOT situations.
• Evaluation and quality control recommendations for new processes relevant to chemistry concerns or to troubleshoot existing processes.
• Development, administration and maintenance of operating and capital budgets.
• Active participation in cGMP inspections and other audits.
• Coordination of departmental staff to conform to cGMP and FK USA policies and procedures.
• Assistance to the organization within areas of expertise as needed.
• Development of people, improvement of methods, and achievement of personal, departmental, and company goals.
• Review of annual product review documents related to the department.
• Development of people, improvement of processes, and achievement of personal, departmental, and company goals.
• Representation of the department at applicable management review meetings.
• Development and harmonization of processes and procedures with peers to improve/enhance compliance, capability, and capacity.
• Ensuring department personnel are aware of Environmental Management and Energy Management Systems.
• Promoting continual improvement and taking accountability for the effectiveness of Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
• Ensuring Health, Safety and Environmental requirements are met under ISO 14001 standards.
• Ensuring Energy Management Requirements are met under ISO 50001 standards.
• Ensuring compliance to Occupational Health and Safety is met under ISO 45001.

Nice To Haves

• Experience with injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition.

Responsibilities

• Directs and prioritizes the functioning of multiple laboratory work teams within the department to provide for the timely and accurate testing of raw materials, in-process and finished goods, to demonstrate that product meets FK USA and FDA regulatory quality requirements.
• Oversees the administration of staff to ensure that members are adequately trained, developed and motivated, and that they adhere to quality performance standards.
• Plans and coordinates training schemes leading to the development of cross-trained, self-directed work teams in line with total quality management concepts.
• Stays current with new and changing analytical chemistry requirements, methods, and pharmaceutical changes.
• Evaluates and decides upon corrective actions to be taken in response to OOS or OOT situations.
• Provides evaluation and quality control recommendations for new processes relevant to chemistry concerns or to troubleshoot existing processes.
• Assists in the development, administration and maintenance of the operating and capital budgets for the department.
• Represents the department with active participation in cGMP inspections and other audits as required.
• Coordinates departmental staffs so that all departmental obligations conform to cGMP and FK USA policies and procedures.
• Provide assistance to the organization within areas of expertise as needed.
• Provide a work environment for the development of people, the improvement of methods, and the achievement of personal, departmental, and company goals.
• Participate in the review of annual product review documents related to the department.
• Provide a work environment for the development of people, the improvement of processes, and the achievement of personal, departmental, and company goals.
• Attends and represents the department at the applicable management review meeting.
• Works with peers within the site and/or at other sites to develop and harmonize processes and procedures to improve/enhance the compliance, capability, and capacity
• Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
• Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
• Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.
• Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Manager