Posted on 8th May 2020
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
The Chemist II position is responsible for the manufacturing of radiopharmaceuticals. As part of the production team, this position will be responsible for process manufacturing of radiopharmaceutical products, preparation of production materials, supplies, general production equipment maintenance and quality control of products.
- Performs chemistry manipulations in Production, Quality Control (QC) and Development
- Use analytical methods and procedures for the QC testing of GMP manufactured radio pharmaceutical products and substances.
- Optimize and validate QC methods and procedures necessary for validating radiopharmaceutical products.
- As part of the production team, this position will be responsible for process manufacturing of radiopharmaceutical products, preparation of production materials and supplies, general production equipment maintenance and the quality control of products.
- Will carry out production responsibilities to meet the manufacturing schedule.
- Assists in the general lab cleaning, stocking of supplies and maintenance.
- Ensures regulatory compliance of production and QC protocols within the manufacturing operations.
- Assists with the implementation of production in manufacturing.
- Assists with creating SOP’s for use in production and QC.
- Compiles, prepares and submits required reports on development projects.
- May assist with the preparation of regulatory submissions including compiling CMC sections of related applications.
- Support and execute Continuous Process Improvement (CPI) initiatives through implementation of Deviation Reporting, OOS and Root Cause Investigations, CAPA, and Change Control.
- Performs other duties as assigned.
- Requires a minimum of a Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering or a related field. An Associates’ Degree in Chemistry or Chemical Engineering along with a minimum of 3 years of related experience working in a pharmaceutical manufacturing environment with preference in Radiopharmaceuticals, may be considered.
- Prior experience with HPLC, Gas Chromatography (GC) and other chemistry related equipment.
- Prior experience working in a GMP environment, preferably within the Pharmaceutical industry, with preference to Radiopharmaceuticals.
- Requires excellent communication, organization, analytical and computer/PC skills (including proficiency in Microsoft Office).
- Demonstrated technical writing skills with experience describing chemical and mechanical processes, production and QC procedures along with validation/qualification protocols.
- Experience working in a team environment.
- Proven abilities to handle responsibilities in a demanding manufacturing environment with minimal oversight.
- While performing the duties of this position, the employee must be able to work under stress, deadlines and able to adapt to changing conditions.
- Occasional exposure to moderate environmental variations, above-normal noise levels, and/or unpleasant substances.
- Occupational exposure to radiation.
- Light to moderate physical exertion, including occasional standing, bending, reaching and occasional lifting and carrying of light to moderate to heavy loads (of up to 90 pounds with assistance).
- Requires good hand-eye coordination
- Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Standard office environment, coupled with work in radiopharmaceutical manufacturing and laboratory environments.
- Must be willing to wear a variety of personal protective equipment.
- Willingness to work in a team based environment.
- Close attention to detail required.
- May be required to sit or stand for long periods of time while performing duties.
- Must be able to work outside of regular work hours.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.