Eli Lilly and Company

Manager-Technology Transfer and CMC Reg

Philadelphia, PA, United States
Dec 03, 2018
Science/R&D, Chemistry
Required Education
Bachelors Degree
Position Type
Full time
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

The Manager is responsible for independently managing projects pertaining to a particular region to establish and maintain the manufacturing of Avid's radiopharmaceutical Drug Products for clinical trial use at contract manufacturing sites. The Manager will manage projects from the start of the technology transfer process through approval of the applicable regulatory filing and maintain sites to ensure reliability of dose delivery.

  • Manage multiple complex technology transfer projects related to the manufacturing and testing of Avid products across a region
  • Manage the maintenance of clinical trial CMOs within a defined region to ensure reliability of dose delivery
  • Ensure performance of CMOs meets applicable objectives
  • Author and review technical documents including standard operating procedures, testing protocols, technical reports, batch files and technical transfer documents for Avid and Contract Manufacturing Organizations (CMOs)
  • Author and review CMC regulatory documents for a particular region as needed
  • Ensure CMOs manufacturing and testing procedures and specifications are in compliance with applicable cGMPs and regulatory documents
  • Be a key resource for manufacturing operations and analytical procedures at CMOs in a particular region
  • Lead and participate in cross-functional teams for projects affecting a particular region

Basic Qualifications
  • B.S. in Chemistry or related field
  • At least 5 years of pharmaceutical industry experience
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences
  • PET drug experience is desirable
  • Fully conversant in cGMPs and regulatory requirements
  • Ability to work independently in a highly focused manner
  • Impeccable organizational skills
  • Superior written and verbal communication skills
  • Excellent computer skills (e.g. Excel, Project, Access)

Additional Information
  • Must be willing and able to travel within the USA and worldwide 20% of time
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status