Pharmaceutical Production Chemist II

Pharmaceutical Production Chemist II

Title | Pharmaceutical Production Chemist II

Location | Totowa, NJ

Department | Radiopharmaceutical Contract Manufacturing

Reports To | Production Manager, Radiopharmaceutical Contract Manufacturing

Overview

The Pharmaceutical Production Chemist II will support the production of new therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Working closely with SOFIE's pharmaceutical partners, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211).

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.
• Lead and organize local production operators and other team members on the technological transfer of production processes (synthesis) utilized for sterile dug manufacturing.
• Lead and execute the qualification of manufacturing processes, validation protocols, and manufacturing validations.
• Prepare SOPs 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.
• Maintain a clean and safe working environment in compliance with hazardous material safety and pharmaceutical regulation.
• 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.
• Other assigned duties as required.
• May require over-time work.

Qualifications

• Bachelor's degree in Chemistry, Biological, or Physical Science required with 2 years of experience in manufacturing of radiopharmaceuticals (qualification, troubleshooting and maintenance) or equivalent combination.
• Experience in a GMP manufacturing environment required.
• 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 required.
• 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.
• Able to lift up to 50 lbs. preferred.
• Travel 10% required.