Aseptic Manufacturing Manager

Lantheus Holdings, Inc. Billerica , MA 01821

Posted 3 weeks ago

Purpose

The objective of this position is to provide management oversight and leadership of operations associated with cold (non-radioactive) product manufacturing on the Billerica Campus, while ensuring that all operations comply with all GMP, OSHA and other regulatory requirements. The first shift Manager leads the execution of commercial pharmaceutical manufacturing according to standard operating procedures and production records in accordance with Current Good Manufacturing Practices (cGMP's). The first shift Manager is responsible for on-the-floor leadership of a team of manufacturing technicians whose primary focus is on execution of the manufacturing processes. In addition to commercial production, the first shift Manager is responsible for compliance with internal and external guidance, technical assessment of the processes, innovation, and reliability. The first shift Manger shall be the technical expert of their team with knowledge required to; maintain a high level of operational efficiency, lead troubleshooting activities, lead investigations, analyze process/equipment data, identify and implement process improvements. A key competency of the first shift Manager's role is effective and timely communication as required to seamlessly execute shift changes in cooperation with the second shift Manager.

Essential Functions

  • Upholds and fosters the Lantheus core values of Accountability, Quality, Efficiency, Customer Service, Collaboration and Safety.

  • Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.

  • Achieves the production schedule by coordinating materials, equipment, personnel, utilities and activities within his/her team, the second shift manager and with partner organizations.

  • Ensures department goals and metrics are meeting or exceeding expectations.

  • Independently identifies deficiencies, creates and executes action plans to mitigate issues.

  • Build strong partnership with process support and facilities teams to ensure operations are supported by on-time maintenance and calibration.

  • Actively promotes a productive and cooperative environment by empowering resources to set and achieve goals together.

  • Develops stretch goals and uses effective motivation techniques to achieve them.

  • Leads response to any developing issues and escalates as appropriate. Initiates response team for critical issues, managing team progress and providing detailed communication to senior management.

  • Leads and/or participates as a team member on investigations driving and executing appropriate CAPAs.

  • Is responsible for the performance of all reporting team members.

  • Establish and maintain the training curriculum for direct reports, as required by all internal policies and external regulatory agencies. Employ training and developmental programs to further enhance technical and organizational skills necessary to support growth objectives.

  • Provide coaching, mentoring and development of staff and provides meaningful and actionable feedback for staff growth and development.

  • Takes an active role in developing less experienced team members. This includes leveraging both internal and external relationships to build the best team possible.

  • Executes all phases of the performance review process with diligence and on time.

  • Demonstrated decision making competence in utilizing the best available information to make the best decision possible.

  • Execute administrative functions to oversee the group. Effectively controls expenses (OT, Supplies, T&E) within their team.

  • Mastery of managing resources to perform work in accordance with SOPs and cGMPs and consistently exceed first-pass quality benchmarks.

  • Extensive knowledge of pharmaceutical manufacturing process with a proven record in pharmaceutical technology, technology transfer, process development, manufacturing support.

  • Drives continuous improvements through staff engagement.

  • Owns and executes OpEx initiatives including 5S.

  • Provides shift continuity by leading the weekly resource planning daily triage meetings.

Typical Minimum Skills and Experience and Education

  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.

  • 2 years of experience leading operational personnel in routine or project settings.

  • Minimum of 2 years of experience in a regulated manufacturing environment

Other Preferred Knowledge and Skills

  • Provides direct audit support.

  • Acts as a consultant to project teams.

  • Able to effectively lead cross functional teams.

  • Effective verbal and written technical communication skills are a must.

  • Demonstrated aptitude for engineering principles and manufacturing automation systems.

  • Operations that the first shift Manager will personally execute and oversee include the following equipment and or systems:

  • Automatic Parts Washers

  • Parts and product sterilizers

  • Vial Washers

  • Depyrogenation Ovens

  • Isolator based Automated Vial Filling Equipment

  • Formulation Tanks

  • Process Automation Systems

  • Computerized systems (ERP, QMS, Maximo, etc.)

  • Routinely scheduled work, and or overtime work required on evenings, weekends, and or holidays and, even in adverse weather conditions. See Essential Personnel Policy.

  • Non-routine overnight travel required based on business need.

  • Routine and or frequent lifting; with reasonable accommodations.

  • Demonstrates a detailed understanding of MRP and inventory control systems and processes.

  • Understands the importance of timely cycle counts and accurate inventory transactions in the realm of the operations and how they affect the Manufacturing/Supply Chain success.

  • Work is performed in a pharmaceutical manufacturing facility within classified areas requiring appropriate gowning, personal protective equipment (PPE) and practices. The role requires handling of hazardous materials such as isopropyl alcohol, acids and oxygen depleting gasses.

  • Develop strong working relationships with other related departments to achieve cross-functional efficiency while operating during first shift, including:

  • Quality Assurance

  • Quality Control

  • Process Support

  • Facilities

  • Engineering

  • Metrology

  • Validation

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Aseptic Manufacturing Manager

Lantheus Holdings, Inc.