Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medicine for more than 50 years, is dedicated to creating and providing pioneering medical imaging solutions to improve treatment of human disease. The company’s proven success in discovering, developing and marketing innovative medical imaging agents provides a solid platform from which to bring forward breakthrough new tools for the diagnosis and management of disease. The company is home to leading cardiac imaging brands, including Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, and TechneLite® (Technetium Tc99m Generator). The company is also now home to ABLAVAR™ (gadofosveset trisodium), a first-in-class blood pool contrast agent for magnetic resonance angiography. Lantheus has more than 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.
In this position, the ideal candidate will work closely with and travel to contract manufacturing sites (CMOs), interacting with both internal and external Manufacturing, Quality, R&D, Regulatory, and Engineering groups as required to maintain and improve process reliability. Manage validation activities with CMOs for process improvements and technical transfer of processes to sites.
Demonstrate ability to work with third party manufacturing by promoting a cooperative effort to improve the various processes by gaining/sharing pharmaceutical knowledge related to equipment, materials and facilities; thus gaining insights into manufacturing issues
Provide updates on external manufacturing processes through the establishment of metrics.
Effectively communicates this information to the appropriate Manufacturing, Quality and Supply Chain teams.
Responsible for writing, approval, and execution of validation protocols to change or transfer manufacturing processes at third party sites.
Demonstrate technical working knowledge of manufacturing procedures and development of process improvements through sound technical and regulatory strategies.
Knowledge of submission package preparation and demonstrated ability to independently communicate with regulatory group(s).
Effectively lead and coordinate project teams through to completion.
Provide technical guidance to other support personnel and establish cross departmental resources to effectively resolve issues.
Work with CMOs to ensure compliance with current pharmaceutical requirements in Regulatory and GMP.
Collaborate with development to understand processes to ensure a smooth transition to commercial manufacturing.
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.
Requirements include a B.S. in Chemistry or Engineering. Advanced degree preferred. A combination of undergraduate degree combined with highly relevant experience would be considered (BS + 10 years, MS + 7 years, PhD +5 years). Must have a strong background in pharmaceutical product development, manufacturing, technical transfer, and commercial launch. Additionally, experience with CMOs is preferred. Must have experience dealing with FDA and other regulatory agencies. Proficiency in GMP’s and regulatory requirements. Must have ability to manage multiple issues effectively.
|Lantheus Medical Imaging|
State or Province