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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_1772577669