Senior Manufacturing Chemist

This position is in our Noblesville, Indiana location and in the role of Senior Manufacturing Chemist. The Chemist 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 (FDA/NRC) environment.

Work Schedule: 8am-4:30 pm

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, SOP's and cGMP.
• 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.).
• Manufacture radiopharmaceutical products, prepare production materials and supplies, perform general production equipment maintenance, and production inventory management.
• Carry out production responsibilities including cross-functional coordination to meet the manufacturing schedule.
• Assist in the general lab cleaning and stocking of supplies.
• Ensure regulatory compliance.
• Create and optimize SOPs as needed.
• Create and execute protocols as needed.
• Support and execute Continuous Process Improvement (CPI) initiatives through implementation of CAPA, protocols and Change Control.
• Author Quality Events as needed (deviations, OOS, CAPA, CC).
• 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.
• Must maintain Class 1 Radiation Worker training qualifications.
• Collateral duties, special projects and other duties assigned by Management.

• Bachelor degree in Chemistry, Biochemistry, Chemical Engineering, or a related field.
• 3 or more years of relevant experience required.
• 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
• Experience working in a GMP environment
• 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.
• Skills/Competencies: Action Oriented, Problem Solving, Decision Quality, Directing Others, Technical Writing Skills, Written Communications, Creativity and Organization
• 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.