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GMP Radiochemistry Specialist
2 months ago
POSITION: GMP Radiochemistry Specialist
Our client, a leader in the field of radiopharmaceuticals, operates a state-of-the-art production facility dedicated to the contract manufacturing of radiopharmaceuticals. This facility adheres to cGMP standards and is compliant with 21 CFR 211 regulations, focusing on late-stage investigational and commercial radiopharmaceuticals.
We are currently seeking a GMP Radiochemistry Specialist to enhance our dynamic and expanding team. The organization provides a competitive salary and benefits package, along with opportunities for professional development.
ROLE OVERVIEW: This role is responsible for executing and refining all processes and protocols utilized in the GMP Clean Rooms for contract manufacturing. The specialist will assist various departments in overseeing the Radiochemistry inventory and documentation, while also offering technical support to production efforts and collaborating with external clients.
KEY RESPONSIBILITIES:
- Collaborate with the Production Department to ensure the safe, efficient, and timely execution of GMP radiochemistry processes.
- Facilitate the irradiation program by preparing targets and conducting radiochemical processing post-irradiation.
- Maintain an accurate physical inventory of all materials assigned to GMP Suites.
- Develop and document new procedures as required.
- Provide technical assistance to Inventory management, sales, and other production departments, including time and labor estimations.
- Engage in the development of new products in partnership with contracted organizations.
- Possess a thorough understanding of research data analysis and interpretation, with the ability to identify and rectify irregularities.
- Exhibit technical leadership and coordinate major installations, materials, tooling, supplies, and scheduling of work crews; collaborate with scientific staff to develop and support technical procedures.
- Communicate effectively, both verbally and in writing, contributing to the formulation of research plans.
- Demonstrate proficiency in MS Office Suite.
- Exhibit attention to detail, accountability, patience, organization, and the ability to work collaboratively in a team environment with minimal supervision.
- Possess strong technical writing capabilities.
QUALIFICATIONS:
- Experience in a GMP manufacturing setting is highly desirable.
- Proficiency in laboratory techniques and analytical chemistry methods is essential (e.g., thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin testing).
- Ability to interpret documents such as safety regulations, operating instructions, and procedural manuals is required.
- Knowledge of cGMP standards, aseptic processes (cleanroom environments), and equipment qualification is necessary.
- Must be capable of safely handling concentrated radioactive solutions.
- Experience operating a hot-cell safely and without contamination is required.
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.
