Summary of Position

The Associate 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 (FDA/NRC) environment. This position is in our Noblesville, Indiana location.

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

Essential Functions

• 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 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 Deviation Reporting, OOS, CAPA, and Change Control.
• 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 and special projects assigned by management.
• Perform other duties as assigned.

Requirements

• Bachelor Degree in Chemistry, Biochemistry, Chemical Engineering, or a related field preferred. Associate Degree in Chemistry with a minimum of one year of experience working in a pharmaceutical manufacturing environment with preference in radiopharmaceuticals may be considered.
• 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.
• 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, nights, overtime, weekends, and holidays.
• Frequent handling of radioactive cyclotron components.
• Responsibilities also include the ability to lift up to 50 lbs, walk, bend, stoop, push, pull, reach, and climb ladders and stairs with or without accommodation.
• Must possess good hand-eye coordination.