Director of Manufacturing

12/23/20

Morristown, NJ 07960

1109

FullTimeRegular

We are looking for an experienced leader with sterile drug manufacturing operations experience to join our team as a Director of Manufacturing Operations. The Director of Manufacturing Operations at our facility leads people, process and systems that manufacture and deliver important sterile pharmaceutical products to our customers as promised. This leadership role is challenging and appeals to people who have a pioneering spirit, driving change and a get the job done right first-time mentality.

Our FDA Registered Outsourcing Facility is a complex operation which requires a leader who has experience in a high-volume sterile manufacturing environment along with advanced people leadership skills. A strong operations mindset with cGMP experience is required to address quality, labor planning, compounding, filling, sterile operations, equipment maintenance, reliability, logistics, automation, safety, productivity, planning and execution. This person will lead Production Management, Production Co-Ordinator, Sterile Technician and Product Support personnel and be responsible to develop and lead, inspire, invent, create culture, foster production, and promote employee retention.

Position Responsibilities

  • Provide hands on leadership and oversight/execution of operational targets
  • Oversight and management of the production staff to meet the site schedule and objectives
  • Responsible for ensuring and enforcing compliance with cGMPs, corporate and site-specific policies and procedures
  • Ensure resources are being utilized on the most impactful activities
  • Management of production area in a safe and compliant manner
  • Set clear objectives, monitor, and report on performance of the operations team in key areas including Quality, Safety, Delivery, and People
  • Mitigate and escalate risks to the appropriate level
  • Managing internal production, investigating deviations, conducting root cause analysis, implementing applicable CAPAs, reviewing batch records, SOPs, change controls, process controls and support process validation
  • Provide technical guidance for complex manufacturing operations
  • Resource planning, staff development and talent and performance management
  • Identify, participate in, and lead continuous improvement (Lean) initiatives throughout the value stream that will improve efficiency, product quality, process effectiveness, and ultimately drive consistent gross margin expansion
  • Develop and maintain performance metrics for site manufacturing activities and communicate department progress to management and staff
  • Work flexible hours as the business demands, including overnight, weekends, and holidays

Skills and Capabilities

  • Strong leadership skills, including demonstrated ability to lead a manufacturing team, and to communicate across all levels of an organization
  • An entrepreneurial approach to develop new, innovative ideas that will drive growth within the manufacturing organization
  • The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion
  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
  • Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues to the executive leadership
  • Develop effective and efficient working relationships

Requirements

  • BA/BS Degree in Business, Science or related field or significant experience
  • 5+ years’ experience in leading a cGMP sterile manufacturing plant operation
  • 10+ years of related experience in cGMP/FDA regulated industry
  • Experience leading 50+ people

Travel

Some travel may be required

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