Our client is a Biotechnology Company headquartered in Houston, Texas, seeking an experienced Senior Radiochemist II to work its newly constructed GMP radiopharmaceutical manufacturing facility. The successful candidate will be critical in R&D, regulatory strategy, method development, and GMP investigations. The focus of the position will be to focus on high-priority projects that will be integral to upcoming clinical trials. This is a newly created position with the potential for significant growth.
The Senior Analytical Radiochemist will provide technical expertise to support the development of analytical methods and procedures that will be used to demonstrate Quality Control (QC) over radioisotope manufacturing processes and clinical dose preparation. This position will also draft documents related to regulatory filings for CMC of DMFs, INDs, NDAs, and FDA/EMA communications. The Senior Analytical Radiochemist II will support the implementation of Laboratory Information Management Systems (LIMS) and quality assurance procedures under 21 CFR 211 and ICH guidelines.
Opportunity for growth