Pharmaceutical Production Chemist I - Advancing Radiopharmaceutical Therapeutics

Join SOFIE, a leader at the forefront of a life-changing industry, where innovation directly translates to purpose. As a Pharmaceutical Production Chemist I, you will be instrumental in the meticulous production of groundbreaking radiopharmaceuticals, directly contributing to the advancement of modern medicine and patient care.

Title | Pharmaceutical Production Chemist I

Location | Totowa, NJ

Department | Radiopharmaceutical Contract Manufacturing

Reports To | Production Manager, Radiopharmaceutical Contract Manufacturing

Shift | TBD

Compensation | TBD

Overview

The Pharmaceutical Production Chemist I will be a vital contributor to the production of novel therapeutic radiopharmaceuticals within SOFIE's dedicated Radiopharmaceutical Contract Manufacturing Division. This role involves close collaboration with our esteemed pharmaceutical partners, ensuring that all radiopharmaceuticals are manufactured with the highest standards of quality and are in stringent compliance with all regulatory requirements, particularly 21 CFR 211.

Essential Duties and Responsibilities

• Skillfully operate, meticulously maintain, and accurately report process data from advanced automated and semi-automated radiopharmaceutical manufacturing equipment.

• Precisely prepare all necessary materials and consumables for manufacturing processes, conducting thorough system checks on equipment prior to use in aseptic environments.

• Execute critical manufacturing activities within controlled ISO-7 and ISO-5 environments, adhering to strict cleanroom protocols.

• Adhere rigorously to detailed instructions outlined in Master Batch Records, promptly recognizing and reporting any deviations during batch manufacturing to ensure product integrity.

• Conduct comprehensive line clearance and pre-batch cleaning activities on the production line, maintaining an impeccable manufacturing setup.

• Actively participate in and execute the qualification of manufacturing processes, develop and implement validation protocols, and perform manufacturing validations to meet regulatory standards.

• Contribute to the development and preparation of Standard Operating Procedures (SOPs) for manufacturing and production activities, as well as validation protocols for production processes and equipment, including drafting comprehensive final reports.

• Support and contribute to the efficient production of a diverse portfolio of radiopharmaceutical products.

• Proactively initiate and author thorough Investigations, Corrective and Preventive Actions (CAPAs), Deviation reports, and Change Control documentation pertaining to drug product manufacturing, including the handling of samples generated for radiopharmaceutical testing.

• Rigorously follow and observe all radiation safety procedures, in strict adherence to regulatory licensing for radioactive material possession and handling. Provide essential radiation safety training to other staff members as needed.

• Engage actively in qualification and validation campaigns for the seamless implementation of new radiopharmaceutical processes, ensuring full compliance with cGMP standards.

• Maintain current approved gowning validation and consistent media fill participation, ensuring authorized access to classified manufacturing areas.

• Uphold a consistently clean, organized, and safe working environment, in full compliance with hazardous material safety guidelines and pharmaceutical regulations.

• Execute all radiation safety duties meticulously, in strict compliance with all applicable regulations.

• Precisely package manufactured drug products, ensuring their safe and compliant shipment to clinical sites.

• Ensure efficient and compliant adherence to all waste management rules and regulations.

• Participate in required internal and external meetings, contributing effectively to discussions.

• Undertake other duties as assigned, demonstrating flexibility and adaptability to evolving operational needs.

• Flexibility to work overtime as operational demands require.

Qualifications

• A High School Diploma is required; a Bachelor’s degree in Chemistry, Biological, or Physical Science is strongly preferred and highly valued for this role.

• Demonstrated experience in a GMP manufacturing environment is highly preferred.

• Proficiency in the use and maintenance of automated synthesis modules is a significant advantage.

• Proven ability to accurately read, interpret, and apply complex documents including safety rules, operating and maintenance instructions, and detailed procedure manuals is essential.

• Strong knowledge of current Good Manufacturing Practice (cGMP) requirements, aseptic processes (within cleanroom environments), and equipment qualification is preferred.

• Proficiency in the use of MS Office Suite is required.

• Candidates must be highly detail-oriented, accountable, patient, and capable of working effectively in a team environment with minimal supervision. The ability to quickly learn and understand multiple scientific and operational disciplines is crucial. Prior experience with HAZMAT worker compliance and/or Radiation Worker compliance is required, given the occupational exposure to ionizing radiation within ALARA (As Low As Reasonably Achievable) principles inherent to this position.

• Flexibility to work multiple or staggered shifts is required to support continuous production operations.

• Ability to lift up to 50 lbs. is preferred.

• Occasional travel, up to 10%, may be required.