Manufacturing Supervisor

Purpose

The objective of this position is to compliantly, lead the on-time, aseptic manufacture of radiopharmaceuticals. Ensures that the integrity and quality of the products produced comply with operating procedures to meet all cGMP, regulatory, and safety requirements. This position requires working in a fast-paced environment, supporting operations on holidays, weekends, and mandatory overtime as needed.

Essential Functions

• Supervise day to day operations, scheduling of Manufacturing personnel, monitoring of workload for weekday operations (plus weekend operations, as applicable) through the application of cGMP’s, safety and performance management policies.

• Utilizes own technical knowledge and/or coordinates resources to resolve complex manufacturing challenges.
• Review production batch records for accuracy and quality.

• Leads and develops staff to achieve professional growth and attain established goals. Establishes personal objectives which complement the team and organizational goals.
• Facilitates clear concise communication between team members, management, and external groups. Supports group involvement on committees. Takes a lead role on committees.

• Collaborates with other departments on joint investigations and root cause analysis to drive effective CAPA.

• Participates in qualification and validation activities to support capacity expansion along with continuous improvements. and ensures methods are current and validated to achieve a high performing, efficient, and flexible work environment.
• Utilizes knowledge and experience to recommend and implement ideas to improve manufacturing processes and develops meaningful metrics used to manage operational performance. Looks to identify leading indicators that may result in process improvements or efficiency of operations.
• Recommends merit increases for team members. Provides appropriate recognition for team members for exceeding expectations. Develops remedial action for team members whose performance does not meet standards.
• Develops and oversees new team members training as well as existing team members cross-training development plans.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
• Actively demonstrates the Lantheus values of help people be their best, respect one another and act as one, own the solution and make it happen, learn, adapt and win and know someone’s health is in our hands.

Minimum Experience and Education

• Bachelor’s degree in a scientific discipline with 5 years relevant experience in the pharmaceutical industry, or equivalent. A combination of education, training, and experience may be considered in lieu of the previous stated requirements.
• Aseptic manufacturing experience is required.
• Radiopharmaceutical experience is a plus.
• Must be detail oriented, strong team player able to influence across levels of management.

Other Requirements

• Must be willing to work with radioactive materials while adhering to prescribed safety procedures.
• Strong knowledge of GMP principals.
• Ability to teach and apply Six-Sigma, 5S, and other Lean processes a plus.