Senior Manufacturing Chemist

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Summary of Position

The Senior Manufacturing 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.

Essential Functions

• 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.
  

Requirements

• 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

LSNJN1448168AJ_1772566692

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