GMP Production Chemist

2 weeks ago

wilmington, United States Masis Professional Group Full time

GMP Production Chemist


Our client is a production facility specializing in the contract manufacturing of radiopharmaceuticals. This new cGMP clean room suite is a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated to late stage investigational and commercial stage radiopharmaceuticals


Currently they are looking to add another GMP Production Chemist to join there happy & growing team The company offers a very generous compensation and benefits package and opportunity for growth


JOB SUMMARY: This position performs and develops all processes and procedures used in the GMP Clean Rooms for contract manufacturing. Supports various departments in managing the Radiochemistry inventory and records. Provides technical support to Production. Works with outside customers and clients.


ESSENTIAL JOB RESPONSIBILITIES:

  • Work under the Production Department director to support production by performing GMP radiochemistry processes in a safe, efficient and timely manner.
  • Support irradiation program through the preparation of targets and radiochemical processing of the targets after irradiation.
  • Support irradiation program through the preparation of targets and radiochemical processing of the targets after irradiation.
  • Maintain physical inventory of all material assigned to GMP Suites.
  • Develop and document new procedures as assigned.
  • Support Inventory management, sales and other production departments through technical assistance and estimation of time/labor.
  • Develop new products in coordination with contracted companies.
  • In-depth understanding and experience with analysis and interpretation of research data, and the ability to recognize and resolve irregularities and invalid results.
  • Ability to provide technical leadership and coordinate major installation, materials, tooling, supplies, and scheduling of work crews; ability to work with scientific or research staff in developing/supporting technical procedures.
  • Ability to communicate effectively, both verbally and in writing and to contribute to the development of the research plan.
  • Proficient in the use of MS Office Suite required.
  • Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required.
  • Strong technical writing skills required.

SKILLS REQUIRED:

  • Experience in a GMP manufacturing environment. Radiochemistry is preferred but not necessary. Candidates from pharmaceutical manufacturing are encouraged to apply.
  • Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.).
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
  • Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required.
  • Must have the ability to work safely using concentrated solutions of radioactivity.
  • Must have the ability to operate a hot-cell safely and without contaminating the equipment.

EDUCATION:

  • BS degree in Chemistry, Radiochemistry or Chemical Engineering and 2+ years’ experience.
  • MS in Chemistry/Radiochemistry with 2+ years’ experience
  • PhD with 1+ years' experience

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