Manager, Production (Formulation)

Fresenius Kabi USA•Grand Island, NY

14d•$90,816 - $126,991•Onsite

About The Position

Manager, Production is responsible for implementation of aseptic filling lines as well as the overall management, direction and coordination of production personnel and processes. Areas of responsibility include but are not limited to formulation, component preparation, aseptic filling, capping and lyophilization.

Requirements

Project leadership skills required
A history of progressive leadership positions in an FDA regulated Pharmaceutical Manufacturing environment
Strong Communication skills
Bachelor’s Degree in life sciences or engineering discipline role
5+ years of experience with 1+ years of experience in a management role

Nice To Haves

Experience with implementing new production lines a plus
Previous experience in Aseptic Pharmaceutical Manufacturing a plus

Responsibilities

Oversees the scheduling, incoming quality control, production operations, quality assurance, engineering, maintenance, equipment validation, training, investigations of non-conformities, laboratory testing contacts, and product release.
Works closely with Validations management, Technology Center, and other support departments during implementation process of new equipment.
With the supervisors reporting to this position, as well as the support departments throughout the plant, the production manager must establish goals for each aspect of the operation, and then develop and implement efficient methods and processes to meet those goals.
Methods and processes will have to both achieve production goals and comply with FDA regulations and plant standard operating procedures.
Coach, train and develop the team to improve their skills, teamwork, and ability to make industry leading, highest quality injectable pharmaceutical products.
Understand the technical aspects of your production operation and troubleshoot equipment, process flow, and product issues.
Develop key performance indicators and measure production results to identify ways to improve product quality, process deviation, scrap rates, labor utilization, regulatory compliance and product yields to reduce bottlenecks and work-in-progress and ensure timely production and resource allocation.
Become involved in quality initiatives through recording and documenting production results, as well as reviewing and approving process changes.