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.
This position is responsible for leading clinical phase stability testing programs, to meet FDA and GMP requirements. This involves creating and managing the stability testing programs for API, API precursors, drug products, analytical standards and other materials as required by CMC development programs. This position is responsible for review of all release and stability data for clinical materials, and for establishing and revising recertification dates of all materials. This position also prepares the stability sections for IND amendments and annual FDA reports.
At this level the incumbent leads independent technical work requiring the application of highly complex scientific/technical processes; is a proven, exceptional technical leader with a track record in multiple technical or research areas; provides leadership in solving specific project/technical problems; leads technical group and provides expertise across functions/ teams; is recognized internally and externally through poster sessions, publications, and peer review.
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.
- Lead group in execution of ICH/GMP compliant release and stability testing program. Manage scheduling, testing and data review.
- Create and gain approvals for stability schedules for all clinical and intended commercial materials used in CMC development.
- Manage material release and recertification process.
- Manage laboratory operations through group members: GMP systems, instrument qualification, calibration, maintenance and repair.
- Perform critical review of test results and drives investigations.
- Serve on company stability review board.
- Develops and delivers technical presentations to group independently.
- Prepares stability tables for IND amendments and annual reports.
- Applies knowledge of site wide policy and implications for Development. Writes SOPs and implements policy.
- Evaluates results and examines implications to program with minimal direction. Accurately documents results in established formats.
- Establishes performance expectations for staff members. Coaches staff on specific performance and professional development issues. Participates in the search and selection of new talent. Fosters diversity and active engagement to improve and sustain morale. Implements proper training and formal performance management as a means to ensuring long-term success.
- Actively manages the resources allocated to ensure efficient utilization. Develops and monitors key metrics of performance. Participates in budgeting, reporting and other administrative functions as required to manage assigned operations.
- BS in scientific discipline such as Chemistry or Biology, with 8 to 10 years experience in pharmaceutical stability programs, or MS in relevant area with 7 plus years experience or equivalent.
- 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.
- Mastery of regulatory requirements for pharmaceutical stability programs
Lantheus Medical Imaging, Inc. - 16 months ago