Senior Analytical Development Chemist Avid Radiopharmaceuticals
Reports To: Senior Director, Analytical Development and Quality Control
Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing novel PET imaging agents with the potential to aid in diagnosis, treatment selection and therapeutic monitoring of serious diseases. For more information, visit www.avidrp.com.
Position Overview: The Senior Research Chemist is responsible for independently contributing to all aspects of analytical development within the Analytical Development and Quality Control Group in support of Avid?s drug development program.
This position reports into the Associate Director, Analytical Development and Quality Control.
?Contribute independently to analytical method development for early stage products and optimization of methods for legacy products
?Provide scientific leadership throughout the Analytical Development and Quality Control Group
?Mentor junior scientists within the Analytical Development and Quality Control Group
?Keep current with US, European, Japanese and ICH regulations and industry standards
?Manage OOS/Deviations/Investigations and Change Control activities related to the analytical documentation and testing
?Support regulatory submissions with high quality analytical documentation by preparing and providing source and specific information for the CMC section
?Manage additional projects within the US and internationally, (e.g. analytical technology transfer, stability studies) as required
?Support release testing for clinical trial material and commercial product and excipients at Avid and through contract organizations
?A minimum of MS degree in chemistry or a related field with at least 5 years of experience or Ph.D. degree with minimum of 2 years of experience in pharmaceutical analytical development
?Strong knowledge of US and international CMC regulatory requirements and cGMPs guidance and their utilization in pharmaceutical development
?Strong knowledge in analytical method development and expertise in separation techniques
?Excellent written and verbal communication skills
?Familiarity with radiochemistry desirable but not required
?Ability to travel within US and internationally as needed
||3624 Market |
Philadelphia, PA 19104