Team Lead, Microbiology
Lantheus Medical Imaging is a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents. For more than 55 years, Lantheus has been dedicatedto 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 purpose of this position is to provide coordination of daily operations to the QC Microbiology Laboratory to ensure compliance with test methodology. Performs testing for stability, raw materials, in-process, and final products for the QC Microbiology Laboratory. Performs review of results of testing. Collaborate with key stake holders to ensure testing is scheduled in accordance with business priorities.
With minimal supervision, performs the following duties as assigned:
- Performs routine microbiological testing such as, environmental monitoring, utilities monitoring, sterility testing, bioburden testing, and endotoxin testing in accordance with SOPs, safety, and GMP guidelines to support quality release of finished products, raw materials, and various components.
- Generate and distribute weekly schedule of routine and non-routine work
- Execute protocols for procedural and instrumentation validations
- Provide problem solving skills to support the resolution and documentation of investigations for laboratory and manufacturing issues.
- Maintain and increase personal scientific, regulatory and compendial expertise and work with lab management to develop organizational capabilities.
- Represent Quality Control in team meetings and projects.
- Is current with various regulatory requirements and procedures.
- Lead and direct group members to ensure cGMP’s and safety policies are followed in the laboratory.
- Ensures calibration and maintenance programs for laboratory equipment are followed.
- Initiates SOP Changes, provide review and coordinate changes in the documentation system
- Perform paperwork review of Laboratory data to ensure accuracy. Review paperwork errors with group members to improve efficiency.
- Communicate with key stake holders to ensure that schedules are met..
- Overtime work is required on weekdays, weekends, holidays, and during adverse weather conditions
- Flexibility to work irregular hours and short notice overtime. Some weekend scheduled work hours are required to support manufacturing operations.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the Lantheus values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
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. Position reports into the Manger, QC Microbiology.
- BS/BA degree in a scientific discipline with a minimum of 3 years of experience in the pharmaceutical industry or related GMP environment, or equivalent.
- Routinely scheduled work, and or overtime work required on evenings, weekends, and or holidays and, even in adverse weather conditions. See Essential Personnel Policy.
- Occasional overnight travel required based on business need. 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.
To apply for this position please visit www.lantheus.com and click on the Career page.
MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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