Summary

Perform routine and advanced testing on incoming materials, finished products and stability studies in QC Laboratory.

Area Specific Requirements

• Perform a wide variety of analytical methods ranging from basic to complex using HPLC, GC, AA, NMR, FTIR, UV, TOC, polagraphic analyzer, DSC, KF, autotitrator instrumentation and compendial wet chemistry methods.

• Group is additionally responsible for the reference standard program. Additional materials tested include raw materials (chemicals), reference standards and solutions used in manufacturing.

Key Responsibilities/Essential Functions

• Perform routine QC testing in accordance with SOPs and cGMP guidelines. Limited supervision required.
• Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor.
• Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
• Utilize a range of electronic systems such as LIMS and document/equipment management software.
• Author and review SOP changes; participate in change controls, CAPAs and other quality systems.
• Resolve routine and more advanced problems by utilizing appropriate resources. Provide problem solving skills to support investigations.
• Participate in protocols for procedural and instrumentation validations.
• Work on special projects as needed. Contribute towards continuous improvement.
• Train on and maintain considerable knowledge of current regulatory requirements and relevant internal procedures.
• Work independently and as a team player with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
• Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
• Promote and actively demonstrate the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.

Basic Qualifications

• Typically requires 3-5 years with a BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous analytical chemistry including HPLC, GC and AA experience preferred.

Other Requirements

• Routinely scheduled work, and/or overtime work required on evenings, weekends, and/or holidays, including during adverse weather conditions. Some non-routine travel may be required.
• Work with (or in proximity to) potentially hazardous chemical materials and must be able to lift/move materials, e.g. gas cylinders, ~10-20 lb bottles of chemicals, and ~25 lb. HPLC waste containers.