GMP Radiochemistry Specialist
2 weeks ago
POSITION: GMP Radiochemistry Specialist
Masis Professional Group is seeking a dedicated professional for a role in a state-of-the-art facility focused on the contract manufacturing of radiopharmaceuticals. This facility adheres to cGMP standards and is compliant with 21 CFR 211 regulations, specializing in both late-stage investigational and commercial radiopharmaceuticals.
ROLE OVERVIEW: The selected candidate will be responsible for executing and refining all processes and protocols utilized within the GMP Clean Rooms for contract manufacturing. This role involves collaboration with various departments to manage the Radiochemistry inventory and documentation, while also providing essential technical support to production teams.
KEY RESPONSIBILITIES:
- Assist the Production Department by executing GMP radiochemistry processes efficiently and safely.
- Facilitate the irradiation program through target preparation and subsequent radiochemical processing.
- Maintain accurate physical inventory of all materials assigned to GMP Suites.
- Develop and document new procedures as necessary.
- Provide technical assistance to Inventory management, sales, and other production departments.
- Collaborate with contracted companies to develop new products.
- Analyze and interpret research data, identifying and resolving any irregularities.
- Offer technical leadership in coordinating installations, materials, and scheduling.
- Communicate effectively, both verbally and in writing, contributing to the development of research plans.
- Utilize MS Office Suite proficiently.
- Exhibit attention to detail, accountability, and organizational skills while working in a team-oriented environment.
- Demonstrate strong technical writing capabilities.
QUALIFICATIONS:
- Experience in a GMP manufacturing setting is highly desirable.
- Proficiency in laboratory procedures and analytical chemistry techniques (e.g., thin layer chromatography, GC, HPLC).
- Ability to interpret safety rules, operating instructions, and procedure manuals.
- Familiarity with cGMP requirements, aseptic processes, and equipment qualification.
- Capability to work safely with concentrated radioactive solutions.
- Experience operating a hot-cell without contamination.
EDUCATIONAL BACKGROUND:
A Bachelor’s degree in Chemistry, Radiochemistry, or Chemical Engineering with a minimum of 5 years of relevant experience is required. Candidates with a Master’s degree in Chemistry/Radiochemistry and 3+ years of experience or a PhD with 1-2 years of experience will also be considered.
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