Category

Description

• Manufacturing Coordination: Provide support in the planning and scheduling of commercial batches, with consideration to demand, capacity, and time requirements and constraints
• Equipment Selection: Liaise with external vendors and internal stakeholders, providing input into equipment selection, purchase, and process decisions
• Quality: Ensure the quality of work, products and services as a first priority; comply with or exceed all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first time measures
• Safety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advances a culture of safety within their team and organization

• Assist in the planning and scheduling of commercial batches
• Supervise and assist in the successful manufacturing of commercial and large-scale clinical batches
• Maintain the inventory system for raw materials components
• Assist in decisions on equipment selection, purchases, and processes
• Lead team in the set-up and change-over of processing equipment
• Ensure manufacturing area and equipment are maintained in accordance with company and regulatory requirements
• Recognize potential problems and provide input on corrective action
• Assist in training staff
• Identify and resolve process and/or equipment failures; initiate appropriate action to prevent reoccurrence

• Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
• Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
• Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
• Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates
• Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas
• Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
• Attention to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
• Communication: Deliver clear, effective communication and takes responsibility for understanding others
• Task Management: Plan work well, maintain flexibility and facilitate change when needed while optimizing quality and productivity

• High school diploma or equivalent with at least six years of equivalent pharmaceutical industry experience
• Associate’s degree with at least five years of equivalent pharmaceutical industry experience
• Bachelor’s degree with at least two years of relevant experience
• Experience in a FDA regulated industry and a thorough functional understanding of pharmaceutical manufacturing processes

• Position requires the ability to lift in excess of 50 lbs unassisted
• Majority of work day is performed while standing, walking, lifting, pulling, pushing
• Requires the ability community effectively using speech, vision and hearing
• Requires the use of hands for simple grasping and fine manipulations
• Requires bending, squatting, reaching, pushing, climbing
• Requires the ability to stand for extended periods of time
• Some exposure to hazardous chemical and other active chemical ingredients
• Must be able to work in a team environment
• Must be able to use a variety of tools, equipment, and machinery

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