Pharmaceutical Manufacturing Specialist
Are you looking to be part of a game-changing organization that has the potential to help cure cancer? Our client is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services.
Position Summary:
The Pharmaceutical Manufacturing Specialist performs duties to support the development and manufacturing of radiopharmaceuticals. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.
Responsibilities:
- Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
- Assist in the accurate and timely preparation and completion of records manufacturing, including Batch Records, Forms, Logbooks, etc.
- Review production Work Orders on the production schedule.
- Author, review, and revise cGMP documentations, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists while upholding QMS guidelines.
- Perform safety checks and routine inspection of the production processing equipment and control systems, consumables, and cleanrooms to ensure compliant manufacturing. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
- Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
- Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with respective policies and procedures.
- Work cross-functionally on employing standardized root cause analysis, investigation tools and methodologies.
- Contribute to interdepartmental projects including production scale-up and continuous process improvement.
Qualifications
- A minimum of an Associate's Degree in a Science, Technology, Engineering, or Mathematics discipline.
- Minimum of two (2) years of cGMP experience.
- CDMO/CMO experience, chemistry experience and knowledge of aseptic processes and equipment qualification preferred.