In this position, the ideal candidate will lead a team to provide both tactical and strategic equipment, automation and maintenance support for GMP Manufacturing operations at Lantheus manufacturing sites and external partners. This individual will identify and address systemic issues affecting operations and be accountable for coordinating responses to all events affecting safety, quality and plant performance. This candidate will build engineering capabilities across three main categories: people, processes and systems. Specifically he/she will develop internal engineering talent, build strong internal business processes, and build strong relationships with internal stakeholders such as Manufacturing, Quality, Finance, Facilities and EHS. This candidate will drive excellence in all aspects of day-to-day manufacturing engineering support for Lantheus.
Key Responsibilities / Essential Functions
Effectively builds organizational capacity necessary to achieve functional objectives and organizational goals, including recruiting and developing strong scientific, technical and leadership talent with a diversity of skill sets. Fosters diversity and active engagement to sustain morale and teamwork. Implements proper training and formal performance management.
Manages manufacturing engineering department activities to ensure quality, cost, and customer service goals are met.
Establishes performance expectations for staff members. Coaches staff on specific performance and professional development issues. Ensures an environment that promotes and rewards the growth and development of workgroups and teams. Promotes and demonstrates the Lantheus values of accountability, quality, efficiency, customer service, collaboration, and safety.
Initiates programs to identify improvements to improve plant reliability, product quality, efficiency, and customer service, including reducing operational costs such as labor, materials, energy and processes. Defines formal evaluation processes to prioritize identified projects. Leads execution of prioritized projects or assigns leadership responsibility to an appropriate staff member.
Leads investigation of equipment/technology based quality event investigations and implementation of CAPA or assigns leadership responsibility to an appropriate staff member. Supports other quality event investigations from an equipment/technology perspective by assigning an appropriate staff member.
Provides support and guidance to the Somerset and CMO manufacturing teams and review business development opportunities where there is a good alignment between a critical business need and group talent, skills or abilities
Regularly communicates strategic and technical information that may affect major business segments and/or functional activities.
Organizes and presents plans in a compelling manner to gain acceptance from target audience.
Maintains current knowledge of, and ensures all functional activities are conducted in compliance with, the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures. Evaluates emerging technologies and offerings by outside vendors.
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Typical Minimum Skills and Experience and Education
BS degree in Engineering
Advanced degree preferred
Experience leading technical groups to establish and achieve business objectives
Experience in troubleshooting, maintenance and operation of GMP Utilities, Aseptic Fill, and Label-Pack operations
Demonstrated ability to lead organization through changes required to improve performance
Demonstrated ability to work through technical, administrative, and compliance issues.
Strong project management skills and experience, including process and equipment design, installation, or major modification
Strong validation experience in multiple aspects of pharmaceutical manufacturing
Demonstrated ability to write and review technical documents, including validation plans, protocols, and reports
Demonstrated proficiency and knowledge of cGMPs, ICH and other worldwide regulatory expectations
Experience interacting with FDA and other regulatory agencies
Strong organizational and communication skills
Effective problem solving skills
Lantheus Holdings, Inc.