GMP Radiochemistry Specialist

2 weeks ago


Wilmington, Delaware, United States Masis Professional Group Full time

GMP RADIOCHEMIST POSITION

Masis Professional Group is seeking a skilled professional for a production facility specializing in the contract manufacturing of radiopharmaceuticals. This state-of-the-art cGMP clean room suite adheres to 21 CFR 211 standards, focusing on late-stage investigational and commercial radiopharmaceuticals.

POSITION OVERVIEW: The selected candidate will be responsible for developing and executing all processes and protocols within the GMP Clean Rooms for contract manufacturing. This role involves collaboration with various departments to manage Radiochemistry inventory and documentation, while also providing technical support to production efforts.

KEY RESPONSIBILITIES:

  • Assist the Production Department in executing GMP radiochemistry processes efficiently and safely.
  • Support the irradiation program by preparing targets and processing them post-irradiation.
  • Maintain accurate physical inventory of materials designated for GMP Suites.
  • Develop and document new operational procedures as required.
  • Provide technical assistance to Inventory management, sales, and other production teams.
  • Collaborate with contracted companies to develop new products.
  • Analyze and interpret research data, identifying and resolving discrepancies and invalid results.
  • Lead technical initiatives, coordinating installations, materials, and scheduling of work crews.
  • 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 the ability to work collaboratively with minimal supervision.
  • 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, preparative HPLC, Radiometric Detectors, endotoxin testing).
  • Ability to interpret safety regulations, operating instructions, and procedural manuals.
  • Knowledge of cGMP standards, aseptic processes, and equipment qualification.
  • Capability to work safely with concentrated radioactive solutions.
  • Experience operating a hot-cell without contamination risks.

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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