The Radiopharmaceutical Contract Manufacturing (RCM) division of SOFIE is looking to solve the problem of maintaining and ensuring compliance of analytical equipment used in the analysis of radiopharmaceuticals with regulatory requirements (21 CFR 211 and 212).
Requirements
- Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.).
- Experience with the use of automated synthesis modules and maintenance of automated modules is preferred.
- Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required.
- Efficient in the use of MS Office Suite required.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
- Strong technical writing skills required.
- Experience in radiopharmaceutical manufacturing and QC in a GMP environment required.
Responsibilities
- Provide maintenance support, troubleshooting, and maintenance of QC equipment (providing ‘on-call’ service, as needed).
- Act as liaison between facilities/maintenance groups and laboratory personnel to schedule preventative and corrective maintenance of equipment.
- Provide technical support and/or training for production staff at SOFIE sites, either remotely or on-site.
- Install, qualify, and maintain laboratory equipment on site.
- Validate existing production or analytical methods on existing or new equipment.
- Author/Review/Execute qualification and/or validation protocols as needed.
- Support the development of protocols for the production and analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards.
Other
- Degree in chemistry, engineering or natural sciences preferred but will entertain applicants with relevant education and work experience.
- 4-years’ experience in radiopharmaceutical manufacturing and QC in a GMP environment required.
- Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required.
- Ability to work various shifts and weekends required.
- Travel: up to 60% domestically.
