Process Support Specialist III
Lantheus Medical Imaging, Inc. - North Billerica, MA

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Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents. For more than 55 years, Lantheus has been dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and commercializing innovative medical imaging agents provides a strong platform from which to bring forward new breakthrough tools for the diagnosis and management of disease.

Lantheus imaging products include DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, the leading ultrasound contrast agent used in ultrasound exams of the heart, also known as echocardiographic exams; ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease; Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), a cardiac imaging agent that is the most successful radiopharmaceutical ever introduced and; TechneLite® (Technetium Tc99m Generator).

Lantheus has approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.

In this position the ideal candidate provides in-person technical support to Manufacturing so that radioactive product manufacturing and distribution schedules are met. Responsibilities include:

Provides in-person technical support to Manufacturing so that radioactive product manufacturing and distribution schedules are met.

Effectively identifies and handles manufacturing challenges in all aspects of manufacturing equipment operation, maintenance, change control and validation.

Routinely utilizes in depth working knowledge across a broad spectrum of equipment support skills including mechanical, electrical, control system engineering, process control, validation, industrial and radiological safety.

Monitors processes using tools such as data browsers and SPC to identify trends and potential problems.

Independently writes complex manufacturing, testing, maintenance and provisional process documentation related to radiopharmaceutical manufacturing.

Proactively identifies problems and provides solutions to those problems.

Troubleshoots highly complex problems with maintenance and calibration of equipment. Proactively adjusts schedules to meet changing priorities.

Sets schedules for multiple resources to ensure business needs are met.

Coordinates highly complex projects.

Organizes and leads project teams or major repairs.

Writes and executes highly complex validation protocols and prepare data summaries for reports.

Performs the duties of a protocol Study Director. Leads project resources through qualification of new equipment and/or processes.

Serves a mentor to other group members.

Participates and or leads in fault-finding and route-cause analysis investigations as a technical resource.

Communicates findings to all levels of the organization.

Provides training, both informal and formal, to other groups to facilitate understanding. Sets priorities for Preventive maintenance and emergency equipment repairs and monitors and adjusts daily/weekly schedules to ensure business needs are met.

Coordinates PMs for other group members. Utilizes own technical knowledge and /or coordinates the proper resources to resolve highly complex manufacturing process problems. Supports group involvement on committees.

Writes, reviews and/or approves the work of other group members, such as validation documentation, aberrant cycle reports, quality incident investigations and change controls.

Provides supervisory coverage on off-hours or during periods when supervision and management are not available. Makes appropriate decisions to ensure the highest quality standards are met when product is released. Serves as the lead of the Process Support group during these periods.

The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards. Additionally, the incumbent will actively demonstrate and promote the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

Responsibilities include:
Bachelor’s degree or preferably > 13 years related experience in a highly regulated manufacturing environment.

Proven record in a radiochemical/radiopharmaceutical support or development environment.

Broad in-depth knowledge of most/all our product processes and operations.

Demonstrated proficiency in utilizing information technologies to analyze data and write technical reports.

Demonstrated ability to write highly complex development and/or validation protocols and reports.

Demonstrated ability to perform the duties of a Study Director for complex development or validation protocols.

Demonstrated ability to lead projects and/or teams for highly complex activities.

Demonstrated ability to plan, implement & execute departmental programs or projects to achieve departmental objectives.

Demonstrated ability to work & lead people, groups & cross-functional groups in a complex, changing, and diverse environment.

Demonstrated ability to continuously improve the manufacturing operation through innovative problem solving and proactive enhancements.

Demonstrated ability to communicate information effectively to all levels of the organization in a manner that promotes productive relationships.

Specific detailed knowledge of all areas within product support (e.g. sterilization, process simulation, component manufacture etc.)

Current in-depth knowledge of cGMPs, radiation safety techniques and regulations.

Advanced understanding of validation principles and methodology.

Advanced, in-depth knowledge of our product processes and operations.

Advanced understanding of scientific principles related to existing product and new product technologies.

Strong knowledge of cGMPs, site safety policies and regulations.

Strong interpersonal skills and an understanding of group dynamics.