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GMP Radiochemistry Specialist

2 months ago

Wilmington, Massachusetts, United States Masis Professional Group Full time

GMP Radiochemistry Specialist

Masis Professional Group is a leading production facility focused on the contract manufacturing of radiopharmaceuticals. Our state-of-the-art cGMP clean room suite adheres to 21 CFR 211 regulations, dedicated to both late-stage investigational and commercial radiopharmaceuticals.

We are currently seeking a skilled GMP Radiochemistry Specialist to enhance our dedicated and expanding team. The organization provides a competitive compensation package along with excellent benefits and opportunities for professional development.

POSITION OVERVIEW: This role involves the execution and development of all processes and protocols utilized in the GMP Clean Rooms for contract manufacturing. The specialist will assist various departments in managing Radiochemistry inventory and documentation while providing technical support to Production and collaborating with external clients.

KEY RESPONSIBILITIES:

  • Collaborate with the Production Department director to facilitate production by executing GMP radiochemistry processes safely, efficiently, and promptly.
  • Assist in the irradiation program through the preparation of targets and the subsequent radiochemical processing of these targets.
  • 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 companies.
  • Possess a comprehensive understanding of research data analysis and interpretation, with the ability to identify and resolve discrepancies and invalid results.
  • Demonstrate technical leadership and coordinate major installations, materials, tooling, supplies, and work crew scheduling; collaborate effectively with scientific or research staff to develop and support technical procedures.
  • Exhibit strong communication skills, both verbal and written, contributing to the formulation of research plans.
  • Proficient in MS Office Suite.
  • Detail-oriented, accountable, patient, organized, and capable of working in a team environment with minimal supervision.
  • Possess strong technical writing abilities.

REQUIRED SKILLS:

  • Experience in a GMP manufacturing setting; radiochemistry experience is preferred but not mandatory. Candidates with pharmaceutical manufacturing backgrounds are encouraged to apply.
  • Proficiency in laboratory procedures and analytical chemistry techniques (e.g., thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin testing).
  • Ability to read and interpret safety regulations, operating and maintenance instructions, and procedural manuals.
  • Familiarity with cGMP requirements, aseptic processes (cleanroom environments), and equipment qualification.
  • Capability to work safely with concentrated radioactive solutions.
  • Experience operating a hot-cell safely without contaminating equipment.

EDUCATIONAL REQUIREMENTS:

  • Bachelor's degree in Chemistry, Radiochemistry, or Chemical Engineering with a minimum of 2 years of relevant experience.
  • Master's degree in Chemistry/Radiochemistry with at least 2 years of relevant experience.
  • PhD in a related field with a minimum of 1 year of relevant experience.