Description

The Aseptic Processing Manager is responsible for leading the activities of the Product Formulation department. The position is also responsible for providing necessary methods and procedures to produce a functional dispensing and formulation process. The Aseptic Processing Manager ensures that documentation and activities in the dispensing and formulation areas are in compliance with SOPs and cGMP guidelines.

Responsibilities:
Maintain an operational knowledge of all Product Formulation equipment and ancillary support equipment.
Establish measurable KPIs for the department and provide feedback to the department on a routine basis, as to the performance to the agreed upon KPIs.
Interface with Process Control, Quality Assurance, Product Development, Bulk, Packaging, Facilities, Supply Chain, Finance, and Human Resources.
Lead strategic development for process improvements to include:
Operational specification
Action Plan for implementation
Analysis of process improvement
Supporting documentation as required
Creating or revising Standard Operating Procedures to support the process improvement
Continuous improvement initiatives
Health, safety, and ergonomic improvements
Develop departmental goals to ensure overall department efficiency and growth.
Budgetary responsibility for all Product Formulation supplies, overtime, and spare parts usage.
Determine design and performance specifications for new processes and equipment purchases.
Provide resources and technical expertise in supporting the success of the development projects.
Ensure the production schedule for Product Formulation is reviewed on a routine basis.
Develop the maintenance program to reliably deliver the department’s goals.
Ensure Product Formulation SOPs and cGMP guidelines are followed.
Ensure department housekeeping meets expectations.
Review and approve documentation as the subject matter expert for the department.

Qualifications

4 year degree in Engineering preferred with a minimum of 5 years progressive leadership experience in a manufacturing environment
Ability to establish priorities and meet expectations with minimal supervision
Ability to lead and develop a team-oriented working relationship within the operation
Excellent communication skills with the ability to motivate department personnel