Production Chemist I

Essential Duties And Responsibilities

• Operate, maintain, and report process data from automated and semi-automated radiopharmaceutical manufacturing equipment.
• Prepare materials/consumables for manufacturing processes and perform system checks on equipment before use in aseptic processes.
• Perform manufacturing activities in ISO-7 and ISO-5 environments.
• Follow detailed instructions in Master Batch Records and recognize and report any deviations from those instructions during batch manufacturing.
• Perform line clearance and pre-batch cleaning activities on the production line.
• Execute the qualification of manufacturing processes, validation protocols, and manufacturing validations.
• Assist in SOP preparation for manufacturing/production activities and validation protocols for production processes and equipment including final reports.
• Contribute to the production of multiple radiopharmaceutical products.
• Initiate and author Investigations, CAPAs, Deviation, and Change Control documentation as related to manufacturing of drug product including samples generated for testing of radiopharmaceuticals.
• Follow and observe all radiation safety procedures in agreement with regulatory licensing of radioactive material possession and handling.
• Provide related training to other staff members as required.
• Participate in the qualification/validation campaign for new radiopharmaceutical process implementation according to GMP standards.
• Maintain approved gowning validation and media fill participation to allow access to classified manufacturing areas.
• Perform radiation safety duties in compliance with regulations.
• Packages manufactured drug product for shipment to clinical sites.
• Efficiently comply with waste management rules and regulations.
• Attend internal and external meetings as required.

Qualifications

• High School Diploma required; Bachelor’s degree in Chemistry, Biological, or Physical Science preferred.
• Experience in a GMP manufacturing environment highly preferred.
• Experience with the use of automated synthesis modules and maintenance of automated modules highly preferred.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
• Knowledge of cGMP requirements, aseptic process (cleanrooms environment), and equipment qualification preferred.
• Efficient in the use of MS Office Suite required.
• Ability to be detail-oriented, accountable, patient, and work in a team environment with minimum supervision required.
• Individual must be capable of learning and understanding multiple disciplines.
• Individual must have previous HAZMAT worker compliance and/or Radiation Worker compliance experience, as occupational exposure to ionizing radiation within ALARA is part of the position.
• Ability to work multiple or staggered shifts required.
• Ability to lift up to 50 lbs. preferred.
• Travel 10% required.