Summary of Responsibilities
Reporting to the Vice President for Process Development, the Associate Director of Analytical Chemistry will be responsible for the generation, review, training and documentation of all analytical testing methods employed in the manufacture of new radiopharmaceuticals at Molecular Insight in compliance with current Good Manufacture Practices.
Specific Responsibilities • Technical review of reports and documents submitted to QA and to RA for regulatory submissions
• Manage analytical instrumentation laboratory and maintenance schedules
• Direct analytical operations of Quality Control personnel
• Monitor Radiation Safety compliance for handling and testing radioactive materials
• Develop new test methods and direct validation efforts
• Monitor adherence to SOPs and oversee version control and compliance
Qualifications • Ph.D. or advanced degree in chemistry, biochemistry or pharmacy with 5-10 years’ experience
• Hands-on experience with HPLC, TLC, GC, UV/VIS, LC/MS/MS and USP compendia methods.
• Strong interpersonal and multi-tasking skills.
• Experience with Word and Excel software.
• Motivated individual who can work in a multi-disciplinary team
• Experience in pharmaceutical GMPs
• Experience in handling of radioactive material and ALARA techniques.
• Experience in the quality analysis of pharmaceuticals or radio-labeled compounds.
Education: An advanced scientific degree is required in pharmacy or chemistry, with experience in the testing and release of pharmaceutical or radiochemical agents for clinical use.