Quality Scientist, Chemistry
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.

The Quality Scientist, Chemistry will be responsible for: Providing support, technical expertise, and testing for stability, raw materials, in-process, and final products in QC Chemistry Laboratory to ensure compliance in test methodology and validations in support of quality release. Performing routine QC Chemistry testing in accordance with SOP’s, safety and GMP guidelines to support quality release of finished raw material and various components. Evaluating laboratory methods, procedures and instrumentation to ensure compliance with current Industry standards. Writing and executing protocols for procedural and instrumentation validations. Contributing technical expertise to investigation, resolution and documentation for laboratory and manufacturing issues. Independently resolving non-routine problems and utilizing a range of established resources. Maintaining and increasing personal scientific, regulatory and compendial expertise and contributing to team objectives and continuous improvements. Representing Quality Control in team meetings and projects providing technical perspective and expertise. Maintaining current with all related regulatory requirements and procedures. Ensuring calibration and maintenance programs for laboratory equipment are followed. Initiating SOP Changes, providing review and coordinating changes in the system. Performing paperwork review of Laboratory data to ensure accuracy. Actively promoting safety rules and awareness, demonstrating good safety practices at all times including the appropriate use of protective equipment. Reporting and taking initiative to correct safety and environmental hazards.

Requirements include a Bachelor’s degree or equivalent in Chemistry, a scientific discipline or related field and three years of work experience in the job offered or related field in the pharmaceutical industry or related GMP environment; or, in the alternative, a Master’s degree or equivalent and two years of work experience.

Special Requirements: Must be able to perform routinely scheduled work, and/or overtime work on evenings, weekends, and or holidays. Must be able and willing to travel domestically and internationally up to 10% of time.

NOTE: This position qualifies for the Lantheus Medical Imaging, Inc. Employee Referral Program. Please contact Human Resources for more information on how to refer candidates for this position.

About this company
Lantheus Medical Imaging is a worldwide leader in medical imaging, with headquarters in North Billerica, Massachusetts, and nearly 700...