Under direction of the Plant Manager, this position determines and directs operations, plans, policies, and organization consistent with Company policies and directly supervises their applications to the areas of responsibility.
Operations include one or more of the following areas: Component Preparation, Solution Formulation, Filling, Autoclaving, and Packaging of Vials and Syringes.
As a Leader and Manager this candidate is expected to be a role model in exhibiting the behaviors and fostering the development of Integrity, Excellence, Collaboration, and Accountability.
- Oversee all operational aspects of the areas of responsibility including but not limited to: safety, quality, service, manufacturing, department operating budgets and efficiencies, cost reduction programs, new product introductions, process improvements, personnel management, and special projects.
- Responsible for seeing operational tasks are performed in a manner which aligns with the Company’s Quality System, Safety and Environmental Management System, and all governing regulatory bodies in the U.S. and Internationally.
- Partner with quality leadership to ensure good quality and cGMP practices and their implementation in manufacturing.
- Develop, coach and mentor all team members.
- Lead, coach and train employees toward team concepts and foster an environment of empowerment and high performance.
- Oversee leadership staff and responsible for ensuring all employees within the area are properly
- trained in areas directly related to their job responsibilities as well as company policies, quality
- policies, and safety/environmental policies.
- Responsible for driving creation and implementation of Cost Reduction Programs.
- Support the site’s Continuous Improvement objectives.
- Drive Continuous Improvement philosophy and practices including but not limited to Six Sigma,
- Lean Manufacturing, TPM, SMED, 5S, and OEE throughout the areas of responsibility.
- Responsible for monitoring weekly schedules and through interface with Planning and Logistics,
- ensure timely customer service.
- Responsible for annual budgeting of staffing, capital, spending and standards.
- Responsible for all special projects assigned by the Plant Manager, to include but not limited to
- Lean Manufacturing initiatives, six sigma projects, safety initiatives, etc.
- Identify and implement career development plans for direct reports.
- Assist Quality Assurance personnel on product specification reviews.
- Conduct departmental and skip level meetings with employees.
- Set clear vision by ensuring goals and objectives are aligned with site strategies through
- performance management for each team member.
- Lead and/or support all investigations, manufacturing exceptions, product failures, RCA and
- customer complaints at the appropriate level with complete and comprehensive detail.
- Directly supervises salaried, direct and indirect labor employees.
- Ability to work flexible hours and respond to emergency calls at all hours
- Occasional travel (less than 10%) to other manufacturing locations for development or to
- support inter-plant collaborative initiatives.
- Manufacturing experience in parenteral/injectable products (required)
- Bachelor’s degree in Engineering, Science or a related field. MBA Preferred.
- 7+ years of manufacturing operations experience in Pharmaceuticals or related field, preferably in a cGMP environment. 7+ years of supervisory/ leadership experience required.
- Packaging and Pre-filled syringe experience required
- Six Sigma or Lean Manufacturing Certification