The individual is responsible for manufacturing support activities, which include CAPA investigations, charge control management, production scheduling and materials management. The manufacturing support lead is responsible for ensuring B5 and B8 manufacturing meet safety, quality, operating costs and production goals for the department. He or she is responsible for hiring and development of the manufacturing support team as well as maintaining current training. The manufacturing support lead must be able to lead through the team to accomplish defined key metrics assigned to the team. Essential Duties and Responsibilities
- Ensure materials are provided to manufacturing on time to meet safety, quality and production goals.
- Identify/prioritize/provide resources to assist core manufacturing to meet annual operating plan and budgetary commitments.
- Manage daily support activities for both B5 and B8 production through subordinates
- Ensure proper training of staff.
- Drive improvements in the area of responsibilities to increase productivity/efficiencies, reduce errors and operating costs.
- Manage overall coaching, training, development and succession plans for team.
- Interfaces with other groups, locally and globally, to ensure smooth manufacturing activities.
- Adheres to all applicable procedures and policies.
- Perform analytical review of data to recommend corrective actions for manufacturing.
- Support plant-wide strategic plans and activities.
Education and/or experience
- Ability to manage activities through subordinates.
- Ability to support manufacturing to meet safety, quality, cost and production initiatives.
- Ability to interpret and analyze statistical data and information.
- Ability to interface with manufacturing and other support groups such as Engineering and Technical Services to drive alignment on priorities to produce effective results.
- Working knowledge of world-class pharmaceutical manufacturing methods such as Lean Manufacturing, Six Sigma, cGMP and CFR guidelines.
- Ability to organize and present technical issues without assistance.
- Ability to understand validation packages and regulatory licenses.
- BS or equivalent with 8-10 years of experience
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required. (only for non-exempt positions)
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.