Manufacturing Chemist

The Manufacturing Chemist position will serve as part of the production team responsible for the processing of bulk radiopharmaceuticals including production preparation and equipment maintenance activities in a highly regulated (i.e. FDA, HC, TGA, EU, NRC, etc.) environment.

Work Schedule: Monday - Friday 8:00am - 4:30pm. Ability to work overtime as needed.

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP's and cGMP.
• Manufacture radiopharmaceutical products, prepare production materials and supplies, perform general production equipment maintenance, and test finished products.
• Optimize and validate QC methods and procedures necessary for validating radiopharmaceutical products.
• Carry out production responsibilities including cross-functional coordination to meet the manufacturing schedule.
• Assist in the general lab cleaning, stocking of supplies, and maintenance activities.
• Ensure regulatory compliance of production and QC products during manufacturing operations.
• Assists with creating and optimizing SOP's for use in Production and QC.
• Create and execute protocols as needed.
• Provide training as needed to Production Chemists.
• Troubleshoot problems including those of a complex nature.
• Develop and promote equipment and process improvements which serve to improve reliability, increase output, and reduce radiation exposure.
• Assist in driving cost savings initiatives for the department. Ensure department safety, quality, and financial metrics are achieved.
• Must actively manage personal radiation exposure as well as exposures of shift personnel per prescribed policies, procedures, and guidelines.
• Support and execute Continuous Process Improvement (CPI) initiatives through implementation of Deviation Reporting, OOS and Root Cause Investigations, CAPA, and Change Control.
• Perform other duties as assigned.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor Degree in Chemistry, Biochemistry, Chemical Engineering, or a related field preferred. Work experience considered in lieu of a degree.
• Three or more years of relevant work experience is required.
• Experience in a pharmaceutical manufacturing environment or working with radiopharmaceuticals is preferred.
• Prior experience working in a GMP environment, preferably within the radiopharmaceutical industry.
• Familiarity with cyclotron solid targets along with the dissolution and separation of radioisotopes preferred.
• Familiarity with radiation protection and safe handling of radioactive materials preferred.
• Demonstrated technical writing skills with experience describing chemical and mechanical processes in support of production and QC procedures along with validation/qualifications protocols.
• Excellent communication, organization, analytical and computer skills (including proficiency in Microsoft Office).
• Proven abilities to handle responsibilities in a demanding manufacturing environment with minimal oversight.
• While performing duties of this position, the employee must be able to work under stress, deadlines and able to adapt to changing conditions.
• Experience with Chemistry related equipment.
• Good team building and collaborative mindset.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.