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 applies analytical and organic chemistry expertise toward the development, validation and transfer of analytical methods for API development. Supports API process development, impurity identification and control, production of clinical phase materials, and qualification of initial commercial vendors. Provides analytical support beyond API when required by overall CMC development program. Reviews and resolves issues involving the properties of a bulk product to ensure acceptability as required by formulation specifications; Writes a range of documentation to support regulatory compliance; Provides technical guidance to others. Generates innovative interdisciplinary projects/programs and is highly authoritative in area of expertise; a leader with a track record on multiple projects and/or programs.
Other responsibilities include:
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.
- Operates as team leader, develops and implements effective plans and contingencies, allocating resources. Oversees the planning and management of multiple development projects involving multiple resources and requiring initiative and innovation.
- Acts as consultant to function for technical solutions for a specialty area within discipline; Exercises judgment and initiative in making project decisions; recommends go/no-go decisions. Devises innovative approaches to complex problems. Identifies, analyzes, and interprets project results. Evaluates results and examines implications to program.
- Independently conducts comprehensive technical presentations to a range of multidisciplinary, internal, and external audiences. Prepares written reports on all phases of experimental work. Presents results to colleagues at scientific meetings and to multidisciplinary audiences in program meetings. Writes comprehensive reports based on literature, lab and field data.
- Keeps abreast of science, literature developments within field, program direction and current business issues.
- Maintains current knowledge of, and ensures all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
- Applies knowledge of site wide policy and implications for Development. Writes SOP’s and develops policy for scientific area. Independently writes reports and procedural documents (PDs) in accordance with established protocols.
- Provides ongoing coaching and performance management to project team. May be responsible for planning, assigning, directing, and evaluating the work of Research Scientists. Improves team’s capabilities and performance as well as maintains accountability for performance and behavior.
- M.S./Ph.D Analytical or Organic Chemistry, Pharmaceutics, or equivalent.
- Usually requires a minimum of 4 – 6 years directly related experience with a Ph.D. degree or 10+ years with a M.S. degree
- Exceptional knowledge of analytical and organic chemistry.
- Significant experience in API analytical and process development support
- Experience in API vendor management
- Demonstrated skills in leading projects with an assigned team.
- 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.
- Supervision of a group of one to five direct reports.
- Mastery of regulatory and GMP requirements for Pharmaceutical Development.