Supervisor QC 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 550 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia.
The objective of this position is to supervise the QC Microbiology laboratory for stability testing, the testing of raw materials, in-process materials, and finished products so that they are performed in a timely and compliant manner based on business need. Ensures the integrity and quality of data generated and that analysts are trained and comply with operating procedures to meet all cGMP and safety requirements. Responsible for all aspects of laboratory operation including: calibration, qualification, and maintenance of laboratory equipment and supplies.
- Supervise day to day operations of the QC Microbiology laboratory including scheduling of laboratory personnel and monitoring of workload for weekday operations (and applicable weekend operations) through the application of company safety, personnel policies and performance management.
- Ensures that product testing is performed per established SOP’s and the collection and maintenance of data are performed in accordance with cGMP’s, Lantheus Medical Imaging's standards and policies and other regulatory requirements.
- Participates in continuous review/upgrade of product testing functions and ensures method are current and validated to achieve a high performing, efficient and flexible work environment.
- Interface with external regulatory inspectors from FDA, EMEA, etc., internal compliance auditors during in-plant inspections in relation to product testing. Ensure timely completion of any corrective and preventive actions (CAPA).
- Provide a strong Quality commitment by maintaining a thorough knowledge of current and emerging US and International guidelines (FDA, USP, cGMP)
- Ensures maintenance of a safe working environment and a staff trained in safety consciousness.
- Leads staff to achieve professional growth and attain established departmental goals. Recommends merit increases for lab staff. Provides appropriate recognition for staff for exceeding expectations. Manages under performing staff.
- Participates in staffing decisions to ensure that there are adequate laboratory resources to meet business needs.
- Write and review investigational reports, SOPs, validation protocols/reports and Quality Events (deviations, investigations, CAPAs)
- Participates in the budgeting process, ensures lab expenditures are in line with budget.
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, quality, efficiency, customer service, collaboration and safety. Position reports into the Manger, QC Microbiology.
Skills and Experience:
- 8-10 years working experience (4 years with MS) in a pharmaceutical Microbiology or related environment with 2-4 years supervisory experience.
- Bachelor’s degree in Biology (Microbiology preferred). Non biology degree holders may be considered if sufficiently experienced.
- Experience writing protocols, procedures, reports, and investigations.
- Must have broad knowledge of cGMPs and laboratory compliance requirements.
- Knowledge of data analysis with appropriate statistical evaluation and trending required.
- Ability to lead and direct work of others effectively.
- Must be able to manage multiple priorities for self and staff and respond to ever changing priorities without issue.
- Must be detail oriented with the ability to multitask and manage multiple projects effectively, strong team player, and be able to collaborate and interact well with all levels of management.
- Familiar with electronic tools (LIMS, BPCS, QETS, etc.)
- Supervision of a staff whose daily function requires the handling of radioactive and hazardous material. Personal Protective Equipment will be provided.
To apply for this position please visit www.lantheus.com and click on the Career page.