GMP Radiochemistry Specialist

1 week ago

Wilmington, Massachusetts, United States Masis Professional Group Full time

GMP RADIOCHEMIST POSITION

Our client, a leading entity in the contract manufacturing of radiopharmaceuticals, operates a state-of-the-art cGMP clean room facility that adheres to 21 CFR 211 regulations. This facility is dedicated to the production of late-stage investigational and commercial radiopharmaceuticals.

They are currently seeking an experienced GMP Radiochemist to enhance their dynamic and expanding team. The organization provides a competitive compensation package along with comprehensive benefits and significant opportunities for professional advancement.

ROLE OVERVIEW: This role involves the execution and development of all protocols and procedures utilized within the GMP Clean Rooms for contract manufacturing. The position supports various departments in managing Radiochemistry inventory and documentation, and offers technical assistance to Production. Collaboration with external clients and customers is also a key component of this role.

KEY RESPONSIBILITIES:

  • Assist the Production Department by executing GMP radiochemistry processes safely, efficiently, and promptly.
  • Facilitate the irradiation program through the preparation of targets and subsequent radiochemical processing.
  • Oversee the physical inventory of all materials designated for GMP Suites.
  • Develop and document new operational procedures as assigned.
  • Provide technical support to Inventory management, sales, and other production departments through time and labor estimations.
  • Collaborate with contracted companies to innovate new products.
  • Possess a thorough understanding of research data analysis and interpretation, with the ability to identify and rectify discrepancies and invalid results.
  • Exhibit technical leadership and coordinate major installations, materials, tooling, supplies, and scheduling of work crews; work collaboratively with scientific or research staff to develop and support technical procedures.
  • Demonstrate effective communication skills, both written and verbal, contributing to the development of research plans.
  • Proficient use of MS Office Suite is essential.
  • Detail-oriented, accountable, patient, organized, and capable of working in a team environment with minimal supervision.
  • Strong technical writing capabilities are required.

QUALIFICATIONS:

  • Experience in a GMP manufacturing setting is highly desirable.
  • Proficiency in laboratory procedures and analytical chemistry techniques is required (including thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin testing, etc.).
  • Ability to interpret safety rules, operating and maintenance instructions, and procedural manuals is necessary.
  • Knowledge of cGMP standards, aseptic processes (cleanroom environments), and equipment qualification is required.
  • Must be capable of safely handling concentrated solutions of radioactivity.
  • Experience operating a hot-cell safely and without contamination is essential.

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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