This role is responsible for implementing the strategic direction for focused factory manufacturing operations.  This includes developing an effective team, aligning human and physical resources to ensure there is a sustainable supply of quality products to meet market demands.  This role is responsible for assuring all aspects of planning, resourcing and manufacturing products is done in an efficient, timely and compliant manner.   Identify and implement best practices in manufacturing, equipment, scheduling and infrastructure suitable to the scope and size of the business through employment of Lean methodologies and tools to accomplish business objectives.   Implement effective use of facilities and personnel with a focus on conformance to schedules and budget.  The position directs the activity of all manufacturing areas including for all products manufactured in the focused factory.  It is accountable for the three key competitive elements of quality, cost and delivery for the assigned value stream.

Responsibilities

• Ensure compliance with safety and quality standards in all areas.


• Ensure the highest level of product quality and required documentation.


• Cross functional collaboration with Quality, Engineering, Supply Chain and Facilities.


• Monitor and control labor and material utilization for maximum efficiency and value


• Manage all activities for continuous improvement and performance enhancement.


• Drive operational excellence and best practices across the scheduling and manufacturing driving cost reduction.


• Review, revise and approve Batch Records, SOPs, and STPs


• Conduct adequate investigations of non-conformances.


• Plan, develop, coordinate and direct manufacturing methods, processes and operations for new and existing products


• Direct supervisor team to establish priorities for the available workforce and ensure proper execution.


• Strong writing and oral communication skills.


• Computer literacy in Microsoft Word, Excel, and PowerPoint.


• Ability to work under pressure with multiple tasks and deadlines.


• Ability to work independently as well as with key internal and external constituents. 


• Strong organizational skills.


• Ability to multi-task and integrate project segments.

Qualifications

Competencies:

Education / Experience:

Bachelor’s degree in related field.  Five to eight years of professional experience within pharmaceutical industry in similar capacity.  Lean certification through an accredited organization is a plus. PC literate with intermediate proficiency in office application software.  Excellent written and verbal communication skills.

Judgment / Decision Making:

Effectively identifies problems as they occur and takes appropriate steps to solve straight-forward problems. Under general supervision, exercises some judgment in accordance with well-defined policies, procedures, techniques.

Work Environment:

Air-conditioned office environment.  Majority of the time spent sitting at a desk, operating computer and talking on telephone.

Physical Demands:         

Visual and manual dexterity required to perform clerical duties, including operating office equipment and checking documents for accuracy.