SCOPE OF POSITION
Zionexa is looking for a Chemist with experience in the pharmaceutical industry to bring their expertise to our new and exciting international company. The position will be based in the New York City area.
As a Chemist, you will be responsible for the production of radiopharmaceutical products. You will perform chemistry manipulations in Quality Control (QC), Production and R & D. You will prepare production materials, supplies, perform production equipment maintenance and ensure the quality control of the products. Perform tech transfer activities internally and with commercial and academic partners in the U.S. and Europe. You will also update and author SOP and CMC data, and be responsible for QC method development, validation and CMO QC surveillance.
The position will be responsible for:
- Performing chemistry manipulations in Quality Control,
- Production and Research and Development (R&D).
- Developing and optimizing methods and procedures for the manufacturing of radioisotope and radiopharmaceutical products.
- Developing, optimizing and validating QC methods and procedures.
- Technology transfer.
- Overseeing and managing CMO’s in Quality and Production.
- Manufacturing pilot batches and conducting validation testing and related studies.
- Releasing batches.
- Reviewing internal and CMO production QC data.
- Troubleshooting synthesis and QC problems.
- Assisting with developing and maintaining SOP’s and CMC’s for use in QC and in Production.
- Assisting with the preparation of regulatory submissions including CMC sections of related applications.
- Assisting with the implementation of production in manufacturing.
- Preparing and submitting required reports on development projects to management and related organizations.
- Performing analytical methods and procedures for the QC testing of GMP manufactured products.
The successful candidate will have:
- An undergraduate degree in Chemistry, Analytical Chemistry, Organic Chemistry, Radiochemistry or a related field.
- An advanced degree in a related field is preferred.
- A minimum of 3 years of experience working in a chemistry related position, preferably in QC in the pharma and/or radiopharmaceutical industry.
- Prior experience with HPLC, Gas Chromatography (GC) and other chemistry related equipment.
- Prior experience working in a Pharmaceutical or radiopharmaceutical GMP environment.
Some travel required.
Who are we? We are newly created international company developing and commercializing molecular imaging companion diagnostics (CDx) for targeted therapies in Oncology that will help clinicians find the right treatment for the right patient at the right time. We are ZIONEXA.
Come be a part of this exciting journey. For immediate consideration, please submit your resume/cv to: firstname.lastname@example.org.