Director of Manufacturing

at  Lantheus Medical Imaging Inc

The objective of this position is to provide leadership and management oversight of cold (non-radioactive) product manufacturing technical operations on the Billerica Campus, while ensuring compliance with all GMP, OSHA and other regulatory requirements. The Director of Manufacturing leads the manufacturing operations to deliver on-time production of high-quality pharmaceutical product. The Director Manufacturing is responsible for leadership of a cross-functional team supporting the DEFINITY value stream operations (formulation, filling, inspection, and packaging). A key success factor for the Director of Manufacturing is communication, coordination and partnership across the functions supporting GMP operations, including chairing the DEFINITY Site Leadership team. The Lantheus technical operations organization utilizes a tiered accountability model in which the Director of Manufacturing participates at the Tier 1 and Tier 2 level, ensuring achievement of KPIs and effective resolution of escalations. The Director of Manufacturing is responsible to set expectations for compliance with internal and external guidance, technical assessment of the processes, innovation, and reliability.

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.
• A master’s degree in engineering, business administration or biotechnology is preferred.
• 10+ 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 systems.
• Types of Operations that this role is accountable for include but are not limited to:
• Automatic Parts Washers
• Parts and product sterilizers
• Vial Washers
• Depyrogenation Ovens
• Isolator based Automated Vial Filling Equipment
• Formulation Tanks
• Automated inspection, labeling and packaging equipment
• Computerized systems (SAP, 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.

• Upholds, fosters, and demonstrates the Lantheus core values:
• Let people be their best
• Respect one another and act as one
• Learn, adapt and win
• Know someone’s health is in our hands
• Own the solution and make it happen
• Establishes programs, practices, and processes to drive a high-performance culture and an engaged workforce.
• Ensures value stream goals and metrics meet or exceeding expectations.
• Leads the DEFINITY Site Leadership Team including key partners from:
• Environmental Health & Safety (EH&S)
• Quality Assurance (QA)
• Quality Control (QC)
• Manufacturing Science & Technology (MSAT)
• Engineering and Facilities
• Validation
• Supply Chain
• Actively promotes safety rules and awareness, always demonstrating good safety practices. Takes initiative to prevent and correct safety & environmental hazards.
• Builds strong relationships with Quality Assurance and Quality Control, ensuring a culture of compliance with specific attention to risk-based decision making.
• Obtains and disseminates knowledge of product, equipment and process with business partners in MT&D, Engineering and Validation, to build deep organizational strength.
• Partners with Supply Chain Planning to establish the long-term production plan, ensure materials availability for production and is accountable to achieve the production schedule.
• Manages and delegates to ensure manufacturing supervision independently identify deficiencies, the create and executes action plans to mitigate issues.
• 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 and/or participates as a team member on major deviations, investigations and CAPA, making sure that root cause is accurately identified and effective CAPA are implemented.
• Is accountable 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.
• Fostering teamwork and collaboration in the manufacturing environment.
• Provide coaching, mentoring and development of staff and provides meaningful and actionable feedback for staff growth and development.
• Executes all phases of the performance review process with diligence and on time.
• Executes 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 technology transfer, process development, manufacturing support.
• Drives continuous improvements through staff engagement.
• Ensures shift continuity by maintaining daily/weekly/monthly staff meetings.