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.
The ideal candidate will be part of the analytical development group and will perform method development, validation and transfer studies. As an analytical lead for manufacturing site qualification, this role will provide analytical support to drug product manufacturing sites for analytical troubleshooting and OOS and deviation investigations.
Perform and author method validation and technical transfer protocols and reports.
The candidate will review contract manufacturing site documents including batch records, master formulas, raw material specifications and analytical methods.
Experience with HPLC and GC method development and validation.
Experience with OOS/Deviation Investigations and CAPAs
Troubleshoot technical issues and improve product quality by providing technical guidance to CMO.
Work with contract manufacturing organizations in the development, optimization, technical transfer and validation of analytical methods and tests for small molecule drug substances and drug products.
Significant experience in analytical, process development and stability program for drug substances and drug products.
Handling of and or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
Fully experienced with cGMPs and all applicable regulations and guidance.
Excellent verbal and written communication skills.
Experience with Positron Emission Tomography (PET) imaging would be a plus.
Ability to travel up to 20%.
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.
BS/MS. in Analytical Chemistry or related filed.
Requires 7-10 years directly related experience with a BS. degree or 5 -7 years with a M.S. degree